The FDA has announced a Class I recall of certain models of Medtronic implantable defibrillators and cardiac resynchronization therapy defibrillators. The statement from the FDA can be found here.
The recall impacts Medtronic’s Evera and Visia brands of ICDs as well as its Viva, Brava, Claria, Amplia and Compia brands of cardiac resynchronization therapy defibrillators (CRT-Ds) implanted from August 31, 2012 to May 9, 2018. The problem is described as “an unexpected and rapid decrease in battery life” caused by a short circuit. The defect may cause devices to go from recommended replacement time (when your alarm sounds to notify you that it is time to schedule a replacement surgery) to full battery depletion in just one day. Normally, you would have approximately 3 months from the time that the alarm first sounds to schedule a procedure to implant a replacement.
According to this article, there have been 444 complaints and 264 medical device reports about this issue which impacts 239,171 devices.
To look up your device by product name, model or serial number to see whether it is impacted, click here.
The box in the upper right corner labeled “Advisories For This Model” will tell you if there are any advisories for your device. If this particular recall affects your device, you will see the same advisory which is circled in red in the photo below.
Patients are advised to continue routine follow ups and use the Care Link Monitoring System.
And, as always, you can call Medtronic Patient Services with any questions at: (800) 551-5544
(M – F, 8am – 5pm Central).