STORY FROM: Drugs & Medical Devices
Medtronic Issues Class I Recall for Defibrillators, Citing Failure to Deliver Electric Shock
March 13, 2018
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 ...