Wearable Automated External Defibrillator
FDA adverse event reports and recall history for wearable automated external defibrillator (product code MVK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 147,670
- Deaths
- 3,718
- Injuries
- 35,966
- Malfunctions
- 107,975
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2018-01-14TerminatedOther
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
- 2010-12-16TerminatedOther
Model 4000 Monitor component of the LifeVest Wearable Defibrillator
The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.
- 2009-01-28TerminatedComponent design/selection
Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
The charging circuit will not shut down properly.
- 2007-10-18TerminatedDevice Design
Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.
- 2007-06-15TerminatedOther
Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.
The electrodes do not properly release conductive gel
Monitor wearable automated external defibrillator automatically
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