An insulation defect appears to be to blame for Medtronic’s massive Class I recall of implantable cardioverter defibrillators (ICDs), including cardiac resynchronization therapy defibrillators (CRT-Ds).
The FDA said it has not yet determined a cause and that Medtronic is investigating. But Medtronic — the world’s largest medical device manufacturer — identified the likely problem in an urgent medical device correction notice sent to healthcare providers.
Medtronic identified 348,616 devices in the U.S. for the recall, distributed from Oct. 13, 201…