Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Keypad buttons on the minimed 640g insulin pumps may become temporarily unresponsive when the atmospheric pressure around the pump increases or decreases rapidly. this would most likely happen when traveling in an airplane during take-off or landing. if this happens, in most cases a patient may not even notice because the pump will resolve this on its own. find attached fsca reporting form for more details.
required.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Medtronic has become aware that specific lots of axiemtm ent suction instruments are not able to pass instrument verification. instrument verification is a step in the software which is performed prior to the use of each instrument. this verification step confirms device tracking functionality and prevents use of the device if a passing verification is not achieved. the impacted devices were made with a particular stainless steel stock material that exhibits magnetic characteristics (magnetic permeability), causing interference with electromagnetic (em) tracking capability of the stealthstationtm.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01015-1
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
A review was completed of all evolut r product complaints that indicated vascular trauma during use of the enveo r delivery catheter system (dcs) from the date of the first commercial evolut r product (august 2014) through may 2016. this review identified a total of 39 events (occurrence rate of 0,136%), each of which reported insertion, advancement, or positioning difficulties associated with complicated patient anatomy (tortuosity, calcification, bicuspid valve, or existing bioprosthesis). the cause of these vascular trauma complaints has been determined to be related to the difficulties maneuvering the enveo dcs in tortuous or highly calcified patient anatomy, which resulted in physicians manipulating or applying extra force to the dcs, leading to vascular trauma in a small sub-set of attempted evolut r implants. there is no indication of any non-conformance or failure of the dcs to meet requirements.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Medtronic records indicate that your facility purchased this product more than five years ago and it is beyond its labeled expiration date.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
During the manufacturing process, medtronic identified small pinholes, approximately 1 mm or less in diameter, in a single packaging configuration of sterile pouches. based on internal investigation, all products in this packaging configuration manufactured since march 1, 2016 are potentially affected.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The potential safety concern identified by the fda “is related to clinical consequences when some patties, which are designed to be x-ray detectable or radiopaque to assist with post-procedural removal in the event of a missing device, are not visible during x-ray imaging.”.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
All lots of symplicity model rdn006 manufactured prior to november 30, 2012, are potentially affected. medtronic has observed a connection issue complaint rate of approximately 5% of devices provided since enrollment of the symplicity ™ htn3 trial began. these connection issues cause unstable temperature readings or lack of signal to the generator. in events where a
connection failure leads to unstable temperature reading, the generator’s safety algorithm is triggered and energy delivery is terminated, or if there is a lack of signal to the generator, it will not initiate treatment, thus in either situation protecting the patient from unsafe treatment.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
This voluntary recall is being conducted due to the potential for a device to be missing the sled component. the sled component is responsible for staple deployment. without the sled, no staples would be deployed. use of a product with this issue may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. medtronic has received four reports of injury related to this issue.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Use of navigate projection feature may lead to display of inaccurate information.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The tubes that used to manufacture the nim flex™ endotracheal tube product, may have the potential to delaminate. investigation has shown that such delamination can result in herniation of the inner lumen when the cuffs are over-inflated. such herniation can constrict the inner lumen of the endotracheal tube resulting in a reduction of airflow to the patient.
Greek data is current through July 2018. All of the data comes from the National Organization for Medicines, 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 Greece.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
Lucas have been experiencing device malfunctions resulting from the failure of a hood probe on the device that connects to the battery. if the device malfunctions it will stop in fail safe mode and the leds will start flickering or the device will switch off.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
This issue occurs when a specific electronic component in your pump malfunctions. it can result in the loss of all audio, problems adjusting the audio volume, or the loss of only the emergency audio siren.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Medtronic has received two reports of patient deaths due to product failure during use in ventricular assist procedures, which are outside the indications for use.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Devices in the affected population may experience rapid battery depletion due to a low resistance path developing within the circuit component.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Through 27 october 2015, medtronic has confirmed 30 devices (0.03%) worldwide have been impacted by this issue, for which the root cause is unexpected high battery impedance.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Manufacturer reinforces warning that device should be used only with medtronic instruments.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The purpose of this letter is to advise you that medtronic has received approval to implement a design change to the synchromed ii implantable drug infusion pump that reduces the likelihood for non-recoverable motor stall, which can cause loss of therapy.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The purpose of this letter is to notify you of information that is being added to the warnings and adverse events sections of medtronic’s deep brain stimulation (dbs) labeling.
( you can find these information in attachment ).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR, TGA
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Medtronic is initiating this voluntary recall because the products identified above may experience a condition that may, in limited circumstances, affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (csf). the condition can occur when the valve mechanism is adjusted to a position that causes a higher than intended flow resistance.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
This letter is to notify you of updates to labeling related to the cycling feature in some neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The purpose of this letter is to advise you that your pump has an error that impacts the arabic language translation. if you do not use the arabic language setting on your pump, you may disregard this message. this translation error does not impact the functionality of the device.
devices do not need to be returned. additionally, we are not aware of this error occurring on any other medtronic insulin pump models.
this translation error occurs in the “predictive alerts” setting screen, which allows you to program alerts that will sound if you are predicted to reach your pre-set low or high sensor glucose values.
for your reference, below is a step-by-step guide on where you will find the arabic language translation error:
1. “main” > “sensor” > “edit settings”
2. select “predictive alerts”, then press “act”. the “predictive alerts high/low” screen may show that the alerts are turned off.
3. select “on”, then press “act”. the “set time sensitivity high/low” screen will appear.
kindly check the photo in the attached fsn
the “ منخفض / مرتفع “ header is incorrectly labelled in the arabic language setting and should instead read “مرتفع / منخفض ”. the value to program the low predictive alert setting is on the left, and the value to program the high predictive alert setting is on the right.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The purpose of this letter is to notify you that labeling is being updated to clarify that the specify 5-6-5 and 2x8 surgical leads are not intended for interoperative trial evaluation use (i.E., trialing/screening outside of the operating room with an external neurostimulator).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Medtronic has identified the potential for an issue with a specific set of lot numbers of neurovascular products listed above where the ptfe (polytetrafluoroethylene) coating applied using the interlock process could delaminate and separate from the corewire. the root cause investigation is still ongoing at this time.