Medtronic has recalled implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators that may fail to deliver life-saving shocks for cardiac patients. [Photo courtesy of Medtronic]
Medtronic identified a likely design flaw that can cause defibrillator implants to halt life-saving shocks for cardiac patients.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…