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 Cobalt and Crome brands of ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) implanted from February 3, 2020 to the present. The problem is described as a “short circuit protection alert resulting in reduced-energy electric shock delivery instead of delivering a second phase of high voltage therapy.” A reduced energy electric shock may fail to correct an arrhythmia or may cause an irregular heartbeat.
There have so far been only 27 complaints, but no injuries or deaths associated with the issue which impacts 87,709 devices total.
Medtronic is developing a software update to address the issue which should be available in late 2022. In the meantime, Medtronic recommends remote surveillance for these patients along with device reprogramming, if necessary.
To look up your device by product name, model or serial number to see whether it is impacted, click here.
NOTE: You can find the name, model and serial number of your device on the plastic identification card provided to you at the time of your implant.
The box in the upper right corner labeled “Customer Communications 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).