FDA Alert: Replace Zoll LifeVest 4000 Displaying Code 102 Immediately

The U.S. Food and Drug Administration (FDA) issued safety communications warning that the Zoll LifeVest 4000, a wearable defibrillator used to treat arrhythmias in adults and children, may fail to deliver treatment if it is not immediately replaced after the device displays a "call for service" code. The Zoll LifeVest 4000 is designed to monitor the hearts of individuals at risk for sudden cardiac arrest that are not candidates for, or refuse treatment through, an implantable defibrillator, but the device may fail to deliver its lifesaving shock if it is not replaced following the display of this code: "Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102."

To date, the FDA is aware of one patient death due to the device's failure to administer a shock after displaying Message Code 102. As of Nov. 14, a total of 33,670 devices were distributed, including 24,975 in the U.S. Of those devices, 0.1 percent have displayed the code. According to the FDA, Zoll will replace the device within 24 hours if it displays Message Code 102. For device replacement or related questions, contact Zoll's 24/7 customer service number, 1-800-543-3267.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ACC Advocacy, Defibrillators, Implantable, United States Food and Drug Administration, Death, Sudden, Cardiac, Arrhythmias, Cardiac, Equipment Failure

< Back to Listings