Medtronic ICD Recall
What is the recall: Medtronic recently issued a class I recall of some of their Medtronic ICDs and CRT-Ds. The reason for this recall is that these devices may deliver a reduced-energy shock instead of delivering a second phase of high voltage therapy.There have been nearly 90,000 of these devices implanted and the FDA says there have been “27 complaints, no injuries, and no deaths associated with this issue.”
Who does it affect:This recall affects only the following Medtronic ICDs: Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). These are devices that were implanted from February 3, 2020 to the present.
Why are these devices recalled:These devices were recalled because they may have a “short circuit protection (SCP) alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy,” according to the FDA.
How to check if it affects me: You can visit the Medtronic website here to look up your device by product name, model or serial number to see if your device is affected.
What should I do if it affects my device: If your device is affected by this recall, you should receive a letter in the mail or a call from your device clinic. If you have not received a letter or call, you can always reach out to your clinic.
What is being recommended: Medtronic is not recommending replacement of these devices.They are recommending that patients with the affected ICDs continue with routine remote monitoring and in-clinic visits. Reprogramming can be performed at your in-clinic visit, if needed.
What is being done: Medtronic is working on a software update to correct this problem. It will be available sometime late this year.
You can read more about the Medtronic recall here.
And please feel free to contact us with any questions!