Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Johnson & johnson testing has shown that, in a small percentage of valves, the following conditions may exist:1. the mri resistance feature may not always operate properly. if this occurs, it could potentially result in an unintended change in the valve setting due to exposure to an mri procedure or other magnetic field. based on reported complaints, this issue may have been a factor in up to 0.06% of units sold.2. the programming mechanism may not always operate properly. if this occurs, it could potentially lead to an inability to modify the operating pressure of the valve with the hand-held programming tools, also referred to as the codman certas therapy management system (tms). based on reported complaints, this issue may have been a factor in up to 0.4% of units sold.
Acción
JJM is recalling the affected units that have not been implanted. For patients that have already been implanted with the device, JJM is providing additional instructions to clinicians to identify whether the implanted device has been affected and what actions to undertake if the device has been affected. For more details, please see http://www.tga.gov.au/safety/alerts-device-codman-certas-valves-130527.htm .
This action has been closed-out on 29/01/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Cycling is a programmable feature which allows the stimulation output of a device to toggle on and off based on programmed settings. enabling cycling at certain parameter settings may decrease the recharge interval for rechargeable devices and the device longevity.In may 2012, the first two cases of premature battery depletion where cycling was programmed at fast rates (0.1s on/off) in conjunction with low patient amplitudes (<3 volts) were reported. both of these reports involved the primeadvanced device model 37702. both devices were explanted, returned and analysed. this inspection, engineering bench testing, and detailed understanding of how the patients used these devices confirmed that specific patient therapy parameters in conjunction with cycling being enabled resulted in a higher current drain on the battery when compared to running the device in continuous mode. higher current drain results in reduced battery longevity.
Acción
Surgeons are advised that the updated calculations and graphs available at professional.medtronic.com/cycling to assess the affect of cycling on device longevity. Surgeons are requested to remind their patients to continue to check battery status. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-neurostimulation-140317.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The tubing within the system that drains csf may leak or disconnect from the joints. leakage and tube separations may result in over- or under-drainage of csf from the ventricular system or introduction of air into the ventricular system (pneumocephalus). this may result in collapsed ventricles, subdural bleeding, or an inability to properly control elevated intracranial pressure. the tubing disconnection or leakage may also increase the risk of ventriculitis. if undetected or untreated each of these events may cause severe brain injury, which may lead to coma, stroke or death. these systems are most often used on neurocritical care floors and these issues are likely to be detected immediately.
Acción
Johnson & Johnson Medical Pty Ltd (JJM) is issuing a two stage recall action to mitigate the risk of shortage for these devices in the market place.
STAGE 1 - INFORM: Inform customers regarding the product issues and what actions need to be undertaken in the interim.
STAGE 2 - RECALL: Customers should return affected product to JJM once they have sourced alternate product.
In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. Manipulation of tubing should be minimised and extra vigilance (identified in the customer letter) is required for early detection of leakage and/or disconnection.
After the alternative products have been sourced by customers, affected products should be quarantined for returning it to JJM.
This action has been closed-out on 28/02/2018,
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Brainlab has detected that, when using the brainlab cranial navigation system, the following may have a significant effect on the overall navigation accuracy: • large distance between reference array and region of interest • major changes of the camera position relative to the reference array during the procedure those instances could potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure. in the worst case scenario, these inaccuracies may cause an inaccurate display of instruments by the navigation system, compared to the actual patient anatomy. if these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual, this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
Acción
Brainlab has developed a software update to improve navigation accuracy. Brainlab will contact their customers to arrange for the installation of the update. This action is a follow-up to RC-2013-RN-00397-1.
This action has been closed-out on 05/12/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
It has been identified that 16 medtronic neuromodulation dbs system pocket adaptors (0.08% reported rate of occurrence) have been identified with high impedance, resulting in decreased current being conducted through the device. some of the reported cases involved loss of therapy, return of symptoms, rebound effects and potential revision surgery to replace the device. there have been no incidents reported in australia. analysis of the returned devices found the cause of the high impedance to be conductor wire fractures near where the wire exits the neurostimulator connector block. in two cases, the issue was identified during implantation surgery, while the other 14 were identified after implantation and resulted in revision surgery.
Acción
Medtronic is reminding users of the device labelling specific to the handling of pocket adaptors and system integrity checking during implant procedures. This action has been closed-out on 03/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic have received three complaints from physicians regarding the dbs depth stop not being adequately secured to the lead. in two of the three complaints received, this resulted in initial dbs lead placement beyond the intended target, which was identified via intraoperative imaging and corrected with no report of patient harm. in the third instance, the issue was identified prior to lead insertion. analysis of these returned products indicate the threaded area of the depth stop screw did not extend far enough to allow it to fully secure the lead in the depth stop causing the slippage of the lead through the depth stop.
Acción
Medtronic is requesting surgeons who suspect that the depth stop is not tightening adequately onto the lead to discontinue use the affected device but instead, to complete the procedure using a depth stop from another Medtronic DBS lead kit. Surgeons are further requested to check the stimulation effect during the implant procedure and use imaging techniques to confirm lead placement, as stated in the DBS lead implant manual. For devices already implanted, surgeons are advised that no action is needed (since lead placement at the intended target location is expected to have been confirmed through intraoperative test stimulation, imaging, and/or therapy effectiveness).
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Brainlab has determined that due to a human error at a brainlab supplier, an unknown number of items within one specific production lot of brainlab drapelink adapters (left/right) were not manufactured according to defined specifications.Due to this manufacturing error the required reproducible rigid fixation between drapelink c-arm array and adapter cannot be ensured in all cases.
Acción
Brainlab is advising users to isolate units with the specified serial numbers from use. A Brainlab Customer Support Representative will contact customers to arrange a service visit to collect and replace the potentially affected item.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic has identified the potential for an issue with all mindframe capture lp devices to partially detach or separate from the delivery wire.
Acción
For affected product that has not been used, Medtronic is advising users to quarantine all unused affected product to prevent further use and return them. A Medtronic representative can assist in facilitating the return of product as necessary.
In situations where the MindFrame Capture LP device stent or stent fragments have been retained, Medtronic is unable to provide specific patient management recommendations at this time due to patient variability associated with these situations. Medtronic is investigating if recommendations can be made to mitigate potential risks associated with this situation and will contact users as soon as possible when these recommendations, if any, become available.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope, Neurological - Product Code GWG
Causa
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Acción
Firm sales representatives will contact customers and hand deliver the recall notice.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There is issues of warmth or heating at the implant site during charging for the eon mini implantable pulse generators (ipgs). in the july 2012 letter st. jude medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the ipg or the ipg is implanted too near the surface of the.
Acción
St Jude Medical sent an Important Medical Device Safety Information letter dated November 30, 2012 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a replacement charger for the Eon Mini IPGs is now available and will be provided at no charge. For questions or concerns call St. Jude Medical at 877-650-0367.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Device, neurosurgical fragmentation and aspiration - Product Code LBK
Causa
There is a potential for erosion of the cusa excel tip used with the nosecone. specifically, the potential for tip erosion occurs when using a cusa cem nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. this erosion can potentially lead to tip breakage. there were no reports of a patient injury associated with these complaints.
Acción
Integra sent a Urgent Medical Device Recall Field Safety Notices dated January 7, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed of the nature of the issue and how if affects CUSA top erosion/breakage; advises customers and provided a copy of the CEM Nosecone IFU additional Warning; and requess customers to complete and return the Acknowledgement Return Form.
Please feel free to contact our service hotline at ( 888 ) 772-7378.