Medtronic Inc.
37 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medtronic Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-01-31FDA-DeviceClass IICobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
- 2024-01-10FDA-DeviceClass IIProtege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Seal defects could compromise the ability of the product packaging to maintain sterility.
- 2023-12-20FDA-DeviceClass IIMedtronic SynchroMed, Model A10
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
- 2023-12-06FDA-DeviceClass IIICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.
- 2023-11-29FDA-DeviceClass IIMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.
- 2023-11-29FDA-DeviceClass IIMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.
- 2023-11-29FDA-DeviceClass IIMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.
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