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Updated Safety Communication: Wearable Cardioverter Defibrillators

March 8, 2019

The Food and Drug Administration (FDA) provided an update on a recall pertaining to the LifeVest 4000 (Zoll Manufacturing Corporation) and its potential to not deliver treatment to patients wearing the cardioverter defibrillator. The FDA is reminding patients and healthcare professionals that if the device displays the message “Call for Service – Message Code 102” to contact the manufacturer immediately for a replacement device.

Additionally, the FDA approved the manufacturer’s new software program that includes a more prominent and persistent alert for Message Code 102. This update is intended to increase awareness and the likelihood of contacting the Zoll Manufacturer Corporation for a replacement device. Adverse events with the LifeVest 4000 should be filed through MedWatch.

The LifeVest 4000 is a wearable defibrillator used to treat life-threatening arrhythmias in adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.

 

Food and Drug Administration (FDA). Update – Zoll LifeVest 4000 Wearable Cardioverter Defibrillator – software update for potential lack of treatment (shock) delivery due to device failure: FDA safety communication. March 6, 2019. Available at: click here. Accessed March 7, 2019.