The flaw that likely caused Medtronic’s massive ICD and CRT-D recall — and why they’re too risky to replace

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…

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