Monday, April 12, 2021

Medtronic Recalls ICDs and CRT-Ds for Risk of Shortened Battery Life

Learn more about Medtronic's Recall of ICDs and CRT-Ds

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US Food and Drug Administration

Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life

Medtronic is recalling the ICDs and CRT-Ds due to an unexpected and rapid decrease in battery life. The decrease in battery life is caused by a short circuit and will cause some devices to produce a "Recommended Replacement Time" (first warning that the battery is low) earlier than expected. Some devices may progress from "Recommended Replacement Time" to full battery depletion within as little as one day. If the user does not respond to the first warning, the device may stop functioning.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Read More

Questions?

If you have questions about this recall, contact the Division of Industry and Consumer Education (DICE).


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