STORY FROM: Drugs & Medical Devices

Medtronic Issues Class I Recall for Defibrillators, Citing Failure to Deliver Electric Shock

WASHINGTON, D.C. - Medtronic is recalling certain of its implantable cardiovert-defibrillators and cardiac resynchronization therapy with defibrillation devices for failure to deliver an electric shock, according to a recent Food and Drug Administration alert.

According to the Feb. 27 safety alert, Medtronic has issued a Class I recall for product codes NIK and LWS, explaining that "the delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient's heart whose heartbeat is too slow could result in serious injury and/or death."

Implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators are devices that provide pacing ...

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