FDA issues Class I recall of certain Medtronic ICDs, CRT-Ds

Editor's Note

The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious.

The recall was initiated because of an unexpected and rapid decrease in battery life, caused by a short circuit. Some devices may progress to full battery depletion within 1 day.

The devices are implanted under the skin and connected to the heart by insulated leads  to provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms.

There have been 444 complaints, 264 Medical Device Reports, and 18 injuries regarding these devices. No deaths have been reported.

Distribution dates for the devices are August 31, 2012, to May 9, 2018.