Zoll LifeVest 4000 Wearable Cardioverter Defibrillator Recall Issued Over Device Failures

Federal health officials warn that Zoll LifeVest wearable defibrillators, which are used to treat life-threatening abnormal heartbeats, may fail to deliver treatment shortly after a service alert is prompted.

A Zoll LifeVest 4000 recall was announced on January 14, and the FDA issued a safety communication on January 17, warning about the risk that the devices may stop supplying life-saving shock treatments shortly after a service warning appears on the device. To date, the manufacturer is aware of one fatality resulting from the devices failing to deliver life-saving shock therapy treatments.

The recalled vests are wearable cardioverter defibrillators used to treat life-threatening abnormal heartbeats in adults and children that are at risk of sudden-cardiac arrest and not candidates for an implantable defibrillator.

The devices are designed to continuously monitor the patient’s heart and, in the event a fast, or life-threatening heart rhythm is detected, will deliver a shock treatment to restore the patient’s heart beat to a normal rhythm.

The FDA is warning all medical professionals and patients that the manufacturing company Zoll Medical Corporation, has determined the devices may sound an alert on the display screen stating “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102”. In the event this message appears, the devices may stop delivering shock treatments during an abnormal heart beat event, posing a serious and potentially fatal adverse health consequences.

According to Zoll Medical Corp., the devices may fail to deliver life-saving shock treatments when needed after the service code appears due to a fault that prevents the device from charging its high-end energy capacitors.

One fatality has been reported to the FDA by the Zoll Medical Corp. that involved a patient who received a Message Code 102 error, and experienced a serious arrhythmia event shortly after, in which the device could not produce the life-saving shock treatment necessary.

The FDA Safety Communication indicates the devices impacted by this potential failure include all Zoll LifeVest 4000 Wearable Cardioverter Defibrillator distributed to cardiologists, electrophysiologists, cardiac surgeons, primary care physicians, and allied health professionals treating patients with heart rhythm problems across the United States.

Zoll Medical Corp. has reported an estimated 33,670 devices have been distributed for sale, with 24,975 devices distributed throughout the United States. According to the FDA, approximately 0.1% of devices in circulation have displayed the error message.

Patients who are using the potentially defective wearable cardioverter defibrillators should contact their cardiologist immediately for a consultation and call Zoll immediately at 1-800-543-3267 for a replacement device if the Message Code 102 appears.