Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: heartware hvad pumps
medical device manufacturer, heartware incorporation, has issued a medical device safety alert concerning its hvad pumps. the affected devices are identified as follows:-
model number: 1104gb
serial number: sterile, un-implanted stock in inventory with serial numbers prior to hw25838
the manufacturer has reviewed certain complaints related to the hvad system and announced a voluntary recall of specified implant kits (pumps) in hospital inventory, which may be more susceptible to electrical faults if the driveline becomes contaminated.
according to the manufacturer, contamination of the driveline-to-controller connector can occur during the implant procedure or post operatively from fluid ingress into the driveline. connector contamination of the driveline has been seen to occur most often in the first 30 days post implant. affected devices that have already been implanted into a patient are not subject for removal.
the presence of fluid or foreign material at the driveline/controller connector may impact the function of the pump and controller. specifically, foreign material at the driveline/controller connector could lead to electrical faults and connection failures. in these scenarios, potential risks include interruption of circulatory support due to a pump stop, which could cause serious injury or death.
the manufacturer has implemented manufacturing process improvements designed to prevent driveline connector contamination in new implant kits. users are advised not to attempt to repair or service any components of the heartware system. if the heartware system equipment malfunctions, they should promptly contact their local representative.
according to the local supplier, the affected serial numbers are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 12 august 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic synchromed implantable infusion pump
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning synchromed implantable infusion pump, manufactured by medtronic.
the synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. although drug is not intended to be delivered to the cerebrospinal fluid (csf) during the priming bolus, mixing of the drug and non-drug (sterile water/csf) fluids occurs at the high infusion rates used during a priming bolus. mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. patients will receive unintended drug at a high rate of infusion in the csf during the priming bolus, and a period of reduced concentration of drug will occur following the priming bolus.
medtronic has performed preliminary bench testing of pumps and catheters to characterize the extent of drug mixing during a priming bolus. it is clear that the amount of drug delivered during the priming bolus procedure is related to the concentration of the drug; however clinical relevance is not fully understood. as part of the evaluation of the priming bolus, medtronic also reviewed previously reported adverse events of overdose, underdose, and death following an infusion system implant or revision. since drug mixing will occur any time the priming bolus is used with a synchromed pump, it is reasonable to expect that the resulting unintended drug delivery is a contributing factor to adverse events involving overdose and underdose. these adverse events will vary depending on the drug being infused, but could include lack of therapeutic effectiveness, confusion or altered mental state, sleepiness, nausea, respiratory depression, coma or death.
medtronic recommends the following published guidance for managing all patients with intrathecal therapy:
continue use of the priming bolus procedure to ensure that therapy is initiated while the patient is under medical supervision.
monitor all patients following start or restart of intrathecal therapy, as recommended in their field safet notice. the post-procedure monitoring period will depend upon specific drug, dose administered and patient co-morbidities.
consider priming the pump prior to implant in the patient and before connection to the catheter (back table prime) to decrease the risk of overdose, especially in patients receiving higher concentration opioid drug solutions and low total daily dose.
educate caregivers and family members to recognize the signs and symptoms associated with intrathecal drug therapy complications.
patients who are receiving intrathecal baclofen and who receive a catheter-only priming bolus with or without a cap aspiration will take longer to reach full intended drug concentration. dose titration may need to be supplemented with oral baclofen to treat spasticity until the optimal intrathecal dose is obtained.
physicians should advise patients to avoid using concomitant drugs that may cause respiratory or cns depression while intrathecal therapy is being initiated or resumed.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con286760
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 17 june 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic consulta crt-p
the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning consulta crt-p [model no.: c3tr01 & serial no.: pzi614815s], manufactured by medtronic.
the manufacturer recently identified an issue with a subset of consulta crt-p devices during production. this issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of a connector bracket. an out-of-specification weld could result in a loss of device hermeticity and compromised device functionality.
the manufacturer is requiring the return of non-implanted devices manufactured between april 1 and may 13, 2013 for re-inspection. furthermore, the manufacturer advises patients implanted with consulta crt-p device to continue to be followed regularly in accordance with product labelling.
for details, please visit the following tga website:
http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00572-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 18 jun 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic sutureless connector intrathecal catheter
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning sutureless connector intrathecal catheter, manufactured by medtronic. the affected products have model numbers of 8709sc, 8731sc, 8596sc and 8578, and a use by date prior to 25 august 2014.
the sutureless connector intrathecal catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. medtronic is removing unused products from the market that were manufactured with the previous design, and recommends the previous design no longer be used due to greater potential for misalignment and subsequent occlusion. replacement of current design products is also available.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con286830
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 19 june 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic synchromed ii and synchromed el pumps
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning synchromed ii and synchromed el pumps, manufactured by medtronic.
within the synchromed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electronic circuitry to the motor. an electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. an electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms.
patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life threatening condition if not promptly and effectively treated. surgical revision to replace or remove the pumps may be required for patients with pumps experiencing repeated motor stalls, low battery resets (with or without safe state), or a premature elective replacement indicator.
all synchromed ii and synchromed el pumps can potentially be affected by this issue at any time throughout the life of the device, regardless of drugs used in the pump. the synchromed el has been discontinued and based on medtronic data, at least 90% of the remaining actively implanted synchromed el pumps are near expected end of service.
medtronic has assessed reports of internal feedthrough shorting in the synchromed ii pump since its release in 2004. there have been 380 relevant product events from approximately 181,400 pump implants worldwide. medtronic’s analysis of returned products and reports data shows the cumulative failure probability for internal feedthrough shorting to be approximately 0.28% at 48 months and 0.69% at 84 months post implant.
for synchromed ii, this issue may be exhibited as one or more of the following:
repeated motor stalls with recovery listed in the pump event log, not associated with temporary exposure to a magnetic field (e.G. mri).
multiple “reset - low battery” errors (critical alarm) listed in the pump event log. after a reset, the pump may change to “safe state”. while in safe state, the pump does not deliver at a therapeutic rate.
premature elective replacement indicator (non-critical alarm), which is one that occurs sooner than expected based on implant duration and flow rate.
for synchromed el, this issue may be exhibited as one or both of the following:
motor stall as determined by rotor study
low battery alarm
medtronic does not recommend prophylactic replacement of synchromed ii or synchromed el pumps due to the estimated low occurrence rate, the presence of pump alarms, and the risks associated with replacement surgery. if repeated short duration motor stalls, low battery resets (with or without safe state), or a premature elective replacement indicator occur, replacement surgery should be scheduled for therapy continuation. alternative medical management should be considered if appropriate. furthermore, the manufacturer provided the following ongoing patient management recommendations:
continue to monitor patients closely for the return of baseline symptoms. a return of baseline symptoms may potentially indicate pump failure.
inform patients about the importance of keeping their pump refill appointments and contacting their physician immediately if the pump alarm sounds or if they notice a change or return of symptoms. remind patients to always carry their patient identification card.
reinforce with patients and caregivers information on the signs and symptoms of withdrawal due to therapy cessation, and the importance of contacting their healthcare provider immediately if the identified signs and symptoms appear.
the synchromed ii pump is designed with both critical and non-critical alarms.
increase the critical alarm interval frequency. the critical alarm interval frequency may be changed to sound every 10 minutes.
remind patients, their caregivers, and your appropriate staff members to be alert for pump alarms.
at implant or follow-up visits, perform an alarm test to provide an opportunity for patients and caregivers to hear and differentiate between the critical and non-critical pump alarms.
for patients with a personal therapy manager (ptm), if there is an active alarm, the ptm will show an alarm code when a bolus is attempted.
retrieve and check logs for critical alarm events when interrogating the synchromed ii pump. note that a motor stall with recovery is expected in the event log when the pump is exposed to a strong magnetic field, such as during an mri. medtronic technical services may be contacted for further assistance evaluating critical alarm events on logs.
for the synchromed el pump:
remind patients, their caregivers, and your appropriate staff members to be alert for the low battery pump alarm.
for suspected motor stalls, perform a rotor study to confirm or rule out a motor stall.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con286830
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 19 june 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic carelink 2090 programmer
the therapeutic goods administration (tga), australia issued a medical device safety alert concerning carelink 2090 programmer manufactured by medtronic. the affected serial numbers are pkk010877r and pkk054660r.
medtronic has identified that a small subset of 2090 programmers have an incorrect software configuration for the country in which that are physically located. when a programmer is manufactured, it is configured for the region in which it will be located. in this way, medtronic is able to differentiate the timing of software updates across different regions of the globe.
through the investigation of this issue, a small subset of programmers have been determined to be physically located in a country outside of the region for which they are configured. medtronic is requesting users to return affected devices for re-configuration.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please refer to tga website:
http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01024-1
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 7 october 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic in.Pact amphirion drug-eluting balloon
the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning in.Pact amphirion drug-eluting balloon (deb) manufactured by medtronic, inc.
based on data from clinical study, the in.Pact amphirion deb did not meet its safety and efficacy endpoints relative to the percutaneous transluminal angioplasty control.
the study also identified a potential safety signal given a trend towards an increased rate of major amputations in the deb study arm.
the manufacturer is advising hospitals to quarantine all units of the in.Pact amphirion deb that remain in their inventory.
according to the local supplier, the affected products were distributed in hong kong.
for details, please visit the following tga website:
http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01153-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 11 november 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic select 3d and select cap arterial cannula
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning all models of select 3d and select cap arterial cannula product families manufactured by medtronic due to reports of the cannula body splitting near the suture collar.. the affected model numbers are 78618, 78620, 78622, 78624, 78718, 78720, 78722, cb78722, 78724, 78818, 78820, 78822, 78920, 78922, 78924, 3y90r3 and c300901b.
since january 2012, the manufacturer has received nine such reported events which represent a 0.06% occurrence rate. of these, one was associated with a patient death and one other was associated with serious injury.
according to the manufacturer, potential patient harms resulting from this type of splitting may include:
the delivery of inadequate blood flow, possibly resulting in ischemia or inadequate perfusion.
difficulty in inserting/removing the cannula tip, possibly resulting in a procedural delay, vessel damage, dissection or other complications that may contribute to patient death.
the manufacturer advises users to identify and quarantine all affected products and return them to the manufacturer.
for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con371783
according to the local supplier, the affected products were not distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 11 february 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers
medical device manufacturer, medtronic, has issued a field safety notice concerning certain models of spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers.
according to the manufacturer, there will be upcoming changes to the adverse event labeling for medtronic spinal cord stimulation therapy. current labeling addresses the potential for neurological complications associated with the surgical implant procedure; however, they do not address the potential for epidural mass formation and subsequent spinal cord compression.
the manufacturer has identified 14 reports over the last 30 years describing delayed spinal cord compression due to an epidural mass around a medtronic spinal cord stimulation (scs) lead. all patients had neurological deficits and required surgical intervention to remove the mass. histologically, the epidural masses consisted of reactive tissue (granulomatous and/or fibrous tissue). the reported time to onset of neurological symptoms after lead implant ranged from weeks to 17 years. the severity ranged from muscle weakness to progressive quadriparesis.
according to the manufacturer, the number of reports corresponds to an estimated rate of occurrence of less than 1 in 10,000 patients. the reports involved various models (8 surgical leads, 6 percutaneous leads). the data indicate that this issue is not limited to specific lead models or lead location (8 cervical, 3 thoracic, and 3 unknown). the frequency of spinal cord compression due to this issue was found to be significantly higher with the use of surgical leads and significantly higher with cervical lead location, but at least one case occurred with a percutaneous lead placed in a thoracic location.
the manufacturer advises users of the followings:
prophylactic removal of scs leads is not recommended.
if a patient with an scs lead presents with a new neurological deficit, spinal cord compression due to reactive tissue mass formation should be considered as a potential cause.
if an asymptomatic epidural mass is identified, periodic monitoring should be considered.
the manufacturer will arrange changes to the adverse event labeling for medtronic spinal cord stimulation therapy.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 13 february 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: alcon accurus standalone vitreous probe paks
medical device manufacturer, alcon, has issued a medical device safety alert concerning its accurus standalone vitreous probe paks [catalogue numbers: 8065741018, 8065750821, 8065751122 and 8065803650].
the manufacturer is conducting a medical device recall for specific lots of its accurus vitrectomy probes due to an insufficient seal on the outside packaging, potentially affecting the sterility of the product. the use of non-sterile vitrectomy probes in surgery can result in patient infection or inflammation. users are advised to stop using and return the affected devices.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 04 june 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic endo-scrub 2 sheaths & tubing set
medical device manufacturer, medtronic, has issued a field safety notice concerning certain lots of endo-scrub 2 sheaths and tubing set. the affected model numbers are as follows:
sheath (with tubing): 1912000, 1912002, 1912004, 1912008, 1912023, 1912024, 1912032, 1912033, 1912038, 1912040, 1912040
tubing: 1912030
the luer connector on the end of the tubing that attaches to the sheath may break off, either prior to or during use. once the connector breaks, the flow of saline to the sheath either ceases or is reduced and leakage occurs at the fracture site.
the manufacturer advises users to continue using the affected sheaths in stock, and not to scrap or return current endo-scrub sheaths. furthermore, the manufacturer will provide users with new tubing to have available and to use if users experience a broken luer connector.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 13 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic synchromed ii implantable drug infusion pump
medical device manufacturer, medtronic, has issued a field safety notice concerning synchromed ii implantable drug infusion pump.
the manufacturer detected an upward shift in reports of occurrence for overinfusion, which is defined as an infusion rate exceeding the programmed infusion rate by more than 14.5% as described in the labeling. when overinfusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn from the pump is less than the volume expected.
the cause for pump malfunction leading to overinfusion remains under investigation and has not been linked to any specific pump lot, drug used, or geographical area.
the manufacturer is not recommending prophylactic replacement of pumps. users are advised to always follow pump refill instructions per the device labeling to allow detection of an overinfusing pump.
the manufacturer advises users to inform them if overinfusion is strongly suspected and return any explanted products to the manufacturer for mechanical and functional analysis.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 18 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic insulin pumps
medical device manufacturer, medtronic, has issued a field safety notice concerning medtronic insulin pumps. the affected model numbers are mmt-511, mmt-512, mmt-712, mmt-712e, mmt-515, mmt-715, mmt-522, mmt-722, mmt-554, and mmt-754.
the manufacturer has received a small number of reports regarding users who have accidentally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycaemia.
according to the manufacturer, when using the express bolus button to deliver a bolus, the down arrow will scroll to 0.0 units and stop. however, all insulin delivery programmed through the main menu will allow the down arrow button to scroll from 0.0 units to the programmed maximum insulin dose.
the manufacturer advises users that because accidental button pressing errors may occur, it is important that patients always confirm the insulin dose flashing on the display is correct before pressing act to start delivery.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 19 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic styker’s berchtold f-generation led lights
medical device manufacturer, medtronic, has issued a field safety notice (fsn) concerning certain styker’s berchtold f-generation led lights with affected model numbers of f528 (with a serial number smaller than 831800001526) and f628 (with a serial number smaller than 831710002819).
there is the potential for electromagnetic interference (emi) between medtronic’s stealthstation axiem or fusion em technology and the abovementioned models of styker’s berchtold f-generation led lights.
when the lights are positioned according to berchtold’s instructions for use – at a distance at least one meter from the patient – there is no interference. when the lights are positioned closer to the patient, the resulting emi causes the stealthstation axiem or fusion em system to cease tracking and display “red status”, which prevents navigation until the emi is removed. the testing confirmed that the stealthstation axiem/fusion system meets specification.
if users have the devices with one of the affected serial number ranges above, they should consider limiting use of the axiem or fusion em system to rooms that do not have these lights installed. if no alternative room is available, customers are reminded to ensure use of the lights according to the berchtold instruction for use, maintaining a light head position at least one meter from the surgical site.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 4 november 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: alcon cypass micro-stent
medical device manufacturer, alcon, has issued a medical device safety alert concerning its cypass micro-stent. the locally affected devices are identified as follow:
model number: 241 (8065754001)
lot number: fg122017005, fg112017003 & fg112017005
the manufacturer is conducting a voluntary field safety corrective action (withdrawal) of all versions of the cypass micro-stent. the stent is indicated for use in the reduction of intraocular pressure in adult patients with mild to moderate primary open-angle glaucoma (poag).
the two-year compass study, which served as a basis for regulatory approvals of the cypass micro-stent for use in conjunction with cataract surgery, included an evaluation of endothelial cell loss (ecl). at two years post-surgery there was little difference in ecl between the cypass micro-stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related ecl.
the compass-xt study was designed to collect safety data on the subjects who participated in the compass study for an additional three years, with analysis of the completed data set at five years post-surgery. at five years, the cypass micro-stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone. a healthy corneal endothelium is responsible for corneal clarity, which is necessary for good vision. endothelial cells do not replicate, and when they are traumatized they are permanently lost. when the number of cells remaining goes below a critical threshold corneal edema (swelling) ensues. corneal decompensation frequently follows, leading to loss of corneal clarity and a subsequent decline in vision. treatment to regain corneal clarity often requires a corneal transplant.
based on information currently available, surgeons should consider the following recommendations for evaluating and managing patients who have been implanted with the cypass micro-stent:
the manufacturer recommends that all patients who have been implanted with a cypass micro-stent undergo post-operative gonioscopy (if not performed previously) to assess stent position, and periodic assessments of endothelial cell density using specular microscopy;
surgeons who are considering stent adjustment or removal should review the information in the cypass micro-stent instructions for use (ifu). healing response and progressive engagement of implant retention features must be factored into the decision to remove the cypass micro-stent after the immediate postoperative period (i.E., after 1 month postoperative). surgeons should consider less invasive intervention such as positional adjustment or trimming of the cypass micro-stent proximal end as a first alternative to device removal. it is highly recommended that surgeons consult the manufacturer prior to device removal;
after the immediate postoperative period, trimming of the proximal end of the cypass micro-stent may be considered when the anterior position of the stent appears likely to compromise corneal endothelial health. there is limited clinical data on the effects trimming may have on ecl. surgeons should consider the risks of further endothelial cell trauma caused by the trimming procedure against the potential benefits of the procedure. a procedure for stent trimming is set out in the ifu.
in addition, the manufacturer advises surgeons to immediately cease implanting the cypass micro-stent. affected users should quarantine any unused products and product removal is on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 29 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation
medical device manufacturer, medtronic, inc., has issued a medical device correction notice concerning interstim, interstim ii, itrel 3 and enterra devices.
the manufacturer is updating the labeling related to the cycling feature in the above neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation.
current labeling indicates the use of cycling improves device longevity under every programming scenario; however, enabling cycling at certain parameter settings may decrease the device battery longevity. furthermore, when cycling is enabled, longevity estimation displayed on the n’vision clinician programmer (model 8840) may not be accurate. the potential hazard would be premature battery depletion requiring an earlier than anticipated device replacement. there is no impact from this issue to therapy delivered or battery level notifications.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 13 january 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic model 5392 dual-chamber external pulse generator
medical device manufacturer, medtronic, has issued a medical device safety alert concerning model 5392 dual-chamber external pulse generator (epg) [serial number equal or lower than djh009999p].
the manufacturer has received reports that the negative terminal of a commercially available aa (lr6) battery did not maintain sufficient connection with the battery drawer electrical contact. this could prevent the epg from powering on or cause the epg to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
the manufacturer advises users to use aa (lr6) batteries where the negative terminal does not have an indentation and has also introduced a new battery drawer contact that is compatible with all aa (lr6) batteries.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 17 march 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic neuromodulation deep brain stimulation system extensions
medical device manufacturer, medtronic, has issued a medical device safety alert concerning neuromodulation deep brain stimulation system extensions [model number: 37085 and 37086 which can be used with neurostimulators: activa pc (model 37601), activa rc (model 37612) and the activa sc (model 37603)].
the manufacturer received complaints of high impedance of extensions and has completed analysis of the 14 extensions returned between october 1st, 2014 and march 2nd, 2015. high impedance for 13 of the extensions was observed at implant and one extension after approximately two months from implant. the manufacturer’s analysis of the returned extensions identified conductor wire fractures in close proximity to the location where the extension exits the connector block and not within the connector block itself.
this issue may result in prolonged surgical procedure or revision surgery depending on when the high impedance / damage is detected. if a damaged extension is not detected during the implant procedure, it could result in loss of stimulation.
the manufacturer advises users to follow the instructions defined within the neurostimulator implant manual related to extension implantation, specifically to ensure that the extension is not bent sharply or kinked to minimize the potential for a conductor wire fracture and to check electrode impedances for open circuits, prior to pocket closure, which could indicate a potential conductor fracture.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 april 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic venaseal closure system model sp-101
medical device manufacturer, medtronic, has issued a medical device safety alert concerning all former sapheon (covidien) venasea closure systems model sp-101.
the manufacturer is conducting a voluntary recall of all former sapheon (covidien) venaseal closure systems due to potential for sterility breach of the outer packaging (pouch) material. a breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray which does not directly affect the sterility of the device components.
the manufacturer has received one complaint potentially related to this issue resulting in an occurrence rate of 0.0253%. this complaint is associated with a serious patient injury; however it is unclear if this injury is device related. there have been no reports of death related to this issue.
according to the manufacturer, the breach in the pouch barrier may not be detectable by visual inspection of the product. while the device components within the sealed inner tray are not directly affected by this issue, the introduction of a non-sterile inner tray (outer surface of the inner tray contaminated) could potentially contaminate the sterile field and sterile personnel, thereby creating a possible indirect pathway for microbes to come in contact with the patient, which may cause an infection. if a patient has received treatment with a venaseal closure system, no action is required and patients should continue to be monitored in accordance with standard of care.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 4 may 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic minimed sure-t infusion sets
medical device manufacturer, medtronic, has issued a medical device safety alert concerning its minimed sure-t infusion sets.
the manufacturer has identified that certain minimed sure-t infusion sets had a slight increase in reports where the steel needle broke during use. in a small number of these reported cases, the needle break led to hospitalization for the management of glucose levels and/or treatment for removal of the needle. since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks.
according to the manufacturer, if a needle break occurs, insulin delivery is interrupted and the pump will not alarm to notify users. the interruption of insulin delivery can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis. the manufacturer advises users to consult their healthcare professional if they experience a needle break while the infusion set is inserted.
the manufacturer will replace the affected products if needed and advises users to follow the instructions for use carefully if they continue using the affected products.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 11 june 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic enveo r loading system
medical device manufacturer, medtronic, has issued a medical device safety alert concerning enveo r loading systems for specific lot numbers of model numbers due to particulate being observed in a small number of cases. the affected devices are identified as follows:
model numbers: ls-enveor-23, ls-enveor-2629, ls-enveor-23-c, ls-enveor-2629-c
lot numbers: 0007266413, 0007408862, 0007462905, 0007515698, 0007573785, 0007332504, 0007408865, 0007476215, 0007515700, 0007573788, 0007332506, 0007408867, 0007476217, 0007515703, 0007573791, 0007332508, 0007408869, 0007476219, 0007522595, 0007579940, 0007332510, 0007428258, 0007482219, 0007522598, 0007579944, 0007343321, 0007428260, 0007482222, 0007522600, 0007579948, 0007343324, 0007428263, 0007482226, 0007522603, 0007579951, 0007343327, 0007435169, 0007486826, 0007530963, 0007592664, 0007350825, 0007439358, 0007492356, 0007530973, 0007592666, 0007350837, 0007439360, 0007495691, 0007537892, 0007592669, 0007354245, 0007439362, 0007495694, 0007537894, 0007592672, 0007366949, 0007456292, 0007495696, 0007569474, 0007598984, 0007369883, 0007456298, 0007508883, 0007569477, 0007254814, 0007393098, 0007462901, 0007508885, 0007569482, 0007354113, 0007393101, 0007462903, 0007508891, 0007573778
through 6 july 2015, the manufacturer has received eight reports related to this issue out of 7,347 potentially affected units. two were reported as particulate being observed in packaged kits and six were reported as particulate being observed in the loading bath during valve loading.
according to the manufacturer, presence of particulate in the enveo r loading system has the potential to be transferred to the transcatheter aortic valve (tav) and released into the patient’s vasculature after deploying the tav. if this were to occur, potential harms may include embolism into the bloodstream.
the manufacturer advises customers to immediately quarantine the unused potentially affected product form their inventory and return them to the manufacturer.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 july 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic elongated one-piece arterial arterial cannula
medical device manufacturer, medtronic, has issued a medical device safety alert concerning its eopa (elongated one-piece arterial) arterial cannula [model number.: 77620; lot number: 2015060544].
the manufacturer is initiating an urgent medical device recall for 221 units of elongated one-piece arterial (eopa) arterial cannula that were shipped without the guidewire. product affected by this issue is limited to a single lot (2015060544) of model 77620. no other devices are affected by this recall. through 29 july 2015, the manufacturer has received two field reports of this issue with no reports of adverse patient effects. in both cases, the missing guidewire was noticed prior to use. further investigation has determined the guidewire is missing due to an isolated manufacturing error that has been addressed.
the eopa arterial cannula is intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. this cannula features a dilator tip introducer to facilitate cannula insertion and priming. the introducer features a guidewire port for use with a 0.038” guidewire. as indicated in the instructions for use (ifu) a guidewire must be used for proper placement of the introducer tip while inserting the cannula to avoid trauma to the back wall of the aorta.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 07 august 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic amphirion deep percutaneous transluminal angioplasty (pta) balloon dilation catheter
medical device manufacturer, medtronic, has issued a medical device safety alert concerning its amphirion deep percutaneous transluminal angioplasty (pta) balloon dilation catheter. the affected products are identified as follow:
model number:amd015020002, amd020120152, amd025150152, amd030150152, amd040120002, amd335210002, amd015020151, amd020150002, amd030040002, amd035040152, amd040120152, amd335210152, amd015020152, amd020150152, amd030040152, amd035120002, amd040150002, amd354210002, amd020040002, amd025040152, amd030080002, amd035150002, amd040150152, amd354210152, amd020040152, amd025080152, amd030080152, amd035150152, amd225210002, amd020080002, amd025120002, amd030120002, amd040040152, amd225210152, amd020080152, amd025120152, amd030120152, amd040080002, amd253210002, amd020120002, amd025150002, amd030150002, amd040080152, amd253210152
medtronic is conducting a voluntary urgent medical device recall of the affected products due to a potential breach of pouch seal for the product manufactured in select lots.
according to the manufacturer, they did not receive any customer complaint or report of adverse patient events regarding improperly sealed pouches. the potential for the breach in the pouch enclosing the sterilized product was discovered during internal packaging testing, which involved exposure to extreme use conditions.
the manufacturer requests the customers to identify and quarantine all unused, affected product in their inventory, and return them to the manufacturer. patients who have received treatment with the devices affected by the recall should continue to be monitored in accordance with the physician’s standard practice.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 26 october 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic covidien curity all purpose gauze sponges, curity x-ray detectable laparotomy sponges, kerlix x-ray detectable laparotomy sponges, vistec x-ray detectable sponges
the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning covidien curity all purpose gauze sponges, curity x-ray detectable laparotomy sponges, kerlix x-ray detectable laparotomy sponges, vistec x-ray detectable sponges manufactured by medtronic.
the manufacturer is recalling specific item codes and production lots of the above products due to the potential for the sterile barrier to be compromised at the package seal. the use of products with this condition may result in a potentially increased risk for infection.
for details, please refer to the mhra website:
https://www.Gov.Uk/drug-device-alerts/field-safety-notices-14-march-to-18-march-2016
if you are in possession of the affected products, please contact your supplier for necessary actions
posted on 22 march 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic bravo ph capsule delivery devices for bravo ph monitoring system
medical device manufacturer, medtronic, has issued a medical device safety alert concerning all lots of its bravo ph capsule delivery devices for bravo ph monitoring system [fgs-0312 (5-pack) and fgs-0313 (1-pack)]
according to the manufacturer, it has received three reports from customers related to patients having allergic reactions to the nickel content in the stainless steel trocar needle that attaches the bravo capsule to the esophageal mucosa. allergic reactions can include hives, itching or oral numbness. there have been no reports of serious injury related to this safety notice.
the manufacturer is adding the following statement to the bravo ph monitoring system user manual and product package insert so that physicians are aware of the nickel content and the potential of an allergic reaction in a patient with nickel sensitivity.
the bravo capsule contains a trocar needle that is made of stainless steel. use caution in patients with known sensitivities or allergies to the metals that are contained including chromium, nickel, copper, cobalt and iron. the bravo ph test lasts from 48-96 hours.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 22 april 2016.