LifeVest Wearable Defibrillator LifeVest 5100 Electrode BeltRecalls & reported problems
Zoll Manufacturing Corporation · Class 3
All models of ZOLL LifeVest (10) · LifeVest Wearable Defibrillator (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This LifeVest wearable defibrillator electrode belt is a wearable defibrillator component. Reports mostly describe circuit failures, structural problems, and false signal readings, including inappropriate shocks. There are 93 reports naming it, with 1 death and 9 injuries, and no recalls name this device. Reports rose sharply, from 17 in the previous 12 months to 73 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 114
- Deaths reported
- 1
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00855778005388), received between Oct 7, 2024 and Sep 30, 2026 — classified as 1 death, 15 injuries, 98 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (83 reports).
6 other recalls cover devices cleared under the same FDA submission (P010030); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Circuit Failure83
- Structural Problem14
- Incorrect Interpretation of Signal12
- Over-Sensing3
- Communication or Transmission Problem2
- Key or Button Unresponsive/not Working2
- Adverse Event Without Identified Device or Use Problem1
- Battery Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- Arrhythmia16
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Circuit Failure
A US distributor reported that a patient's electrode belt could not run detect and treat testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944781 ↗MalfunctionSep 29, 2026Circuit Failure
A US distributor reported that a patient's electrode belt could not run detect and treat testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936698 ↗MalfunctionSep 29, 2026Circuit Failure
A US distributor reported that a patient's electrode belt could not run detect and treat testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936601 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
Patient problems: Arrhythmia
MAUDE report 50933249 ↗MalfunctionSep 29, 2026Circuit Failure
A US distributor reported that an electrode belt was damaged and displaying adjust belt and check pad messages.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931287 ↗MalfunctionSep 29, 2026Circuit Failure
A US distributor reported that a patient's electrode belt could not run detect and treat testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931073 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received three inappropriate shocks. Double counting contributed to the false detection. The response buttons were pressed after treatment. The patient was at facility at time of treatment. The patient did continue use of lifevest. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50930460 ↗InjurySep 28, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. Double counting contributed to the false detection. The response buttons were pressed during the event.The patient did not seek medical attention and did continue use of lifevest. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50920131 ↗MalfunctionSep 28, 2026Circuit Failure
A US Distributor returned an electrode belt was unable to pass essential performance testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916712 ↗MalfunctionSep 28, 2026Circuit Failure
A US distributor reported that an electrode belt had tactile / vibration alarms or lack thereof.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916415 ↗InjurySep 28, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. Double counting contributed to the false detection. The response buttons were not pressed during the event. The patient went to the hospital for further evaluation and continues to wear the LifeVest. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50913571 ↗MalfunctionSep 24, 2026Structural Problem
A US distributor reported that an electrode belt had bent pins or damaged E-Belt connector.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884741 ↗MalfunctionSep 23, 2026Circuit Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872811 ↗MalfunctionSep 23, 2026Circuit Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872733 ↗MalfunctionSep 23, 2026Structural Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872453 ↗MalfunctionSep 15, 2026Circuit Failure
A US distributor reported that an electrode belt was unable to complete incoming functionality testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771845 ↗MalfunctionSep 15, 2026Structural Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771398 ↗MalfunctionSep 15, 2026Circuit Failure
A US distributor reported that an electrode belt was unable to complete incoming functionality testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771169 ↗MalfunctionSep 14, 2026Structural Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761880 ↗InjurySep 10, 2026Incorrect Interpretation of Signal
Patient problems: Arrhythmia
MAUDE report 50722493 ↗MalfunctionSep 8, 2026Circuit Failure
A US distributor returned a belt and reported being unable to complete essential performance testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50665887 ↗MalfunctionSep 5, 2026Circuit Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50630506 ↗MalfunctionSep 4, 2026Circuit Failure
A US distributor returned a belt and reported being unable to complete essential performance testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50610961 ↗InjurySep 3, 2026Over-Sensing
A patient received an inappropriate shock. Motion artifact contributed to the false detection. The response buttons were pressed after the event. The patient went to the hospital for further evaluation and was discharged home. Patient continues to wear the LifeVest.No injury was reported from the treatment. No deficiencies were alleged against the device.
Patient problems: Arrhythmia
MAUDE report 50592010 ↗MalfunctionSep 3, 2026Structural Problem; Key or Button Unresponsive/not Working
A US distributor returned a monitor and reported that the response buttons were non-functional.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591216 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P010030. One submission often covers many models, so check the product and lot details in each record.
- Z-0353-2018 · Sep 12, 2017 · TerminatedLifeVest 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
- Z-0625-2011 · Sep 24, 2010 · TerminatedModel 4000 Monitor component of the LifeVest Wearable Defibrillator
- Z-0883-2009 · Oct 21, 2008 · TerminatedMonitor 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
- Z-0061-2008 · Sep 14, 2007 · TerminatedBattery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
- Z-0936-2007 · Apr 27, 2007 · TerminatedElectrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.
- Z-0578-03 · Jan 10, 2003 · TerminatedLife Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
Other Wearable Automated External Defibrillator devices
- LifeVest Wearable Defibrillator LifeVest 4000 MonitorZoll Manufacturing Corporation · Wearable Automated External Defibrillator2,039 deaths36,128 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Electrode BeltZoll Manufacturing Corporation · Wearable Automated External Defibrillator44 deaths15,404 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery PackZoll Manufacturing Corporation · Wearable Automated External Defibrillator1 death9,929 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery ChargerZoll Manufacturing Corporation · Wearable Automated External Defibrillator1 death6,327 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Electrode BeltZoll Manufacturing Corporation · Wearable Automated External Defibrillator14 deaths4,460 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery ChargerZoll Manufacturing Corporation · Wearable Automated External Defibrillator1 death1,296 reports
- ASSURE WCD System 80014-002Kestra Medical Technologies, Inc. · Wearable Automated External Defibrillator31 deaths930 reports
- LifeVest Wearable Defibrillator LifeVest 5100 Battery PackZoll Manufacturing Corporation · Wearable Automated External Defibrillator557 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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