Device: The Fortify, Unify, and Assura Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators Click here for affected model numbers. Recall reason: According to information on the FDA recall page, there were "reports of rapid battery failure caused by deposits of lithium . . . forming within the battery, and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replace, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death." When recall was initiated: October 10, 2016 Number of U.S. units impacted: 251,346 units For more information, visit the FDA Recall page. |
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[Image courtesy of ST. JUDE MEDICAL]
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