LifeVest Wearable Defibrillator LifeVest 4000 Battery PackRecalls & 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 4000 battery pack for the wearable defibrillator appears in 9,745 adverse event reports: 9,730 describe malfunctions, 14 describe injuries, and 1 mentions a death. The reports mostly describe batteries that fail to power up or charge, and contamination. Reports in the last 12 months number 1,285, down from 2,433 the year before. No recalls name this device.
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
- 9,929
- Deaths reported
- 1
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9,929 adverse event reports that list this exact device (DI 00855778005036), received between Jun 16, 2017 and Sep 30, 2026 — classified as 1 death, 14 injuries, 9,914 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (6,019 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
- Battery Problem6,019
- Failure to Power Up3,399
- Failure to Charge584
- Contamination /Decontamination Problem345
- Charging Problem262
- Defective Device77
- Premature Discharge of Battery36
- Defective Component27
Patient problems
- No Clinical Signs, Symptoms or Conditions5,456
- Insufficient Information2,806
- No Known Impact Or Consequence To Patient1,629
- No Information24
- Skin Inflammation/ Irritation8
- Arrhythmia1
- Atrial Fibrillation1
- Cardiac Enzyme Elevation1
Recent adverse event reports
The 25 most recent of 9,929 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950793 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950660 ↗MalfunctionSep 30, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950547 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950502 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950290 ↗MalfunctionSep 30, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950072 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949904 ↗MalfunctionSep 30, 2026Battery Problem; Contamination /Decontamination Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947793 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947632 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947585 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947541 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947395 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947240 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947054 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946852 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946747 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944496 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944337 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944279 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944207 ↗MalfunctionSep 30, 2026Battery Problem; Contamination /Decontamination Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943856 ↗MalfunctionSep 29, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929750 ↗MalfunctionSep 29, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929686 ↗MalfunctionSep 29, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929670 ↗MalfunctionSep 29, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929665 ↗
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 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
- LifeVest Wearable Defibrillator LifeVest 5100 MonitorZoll Manufacturing Corporation · Wearable Automated External Defibrillator9 deaths482 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.
How reports and recalls are matched · Editorial policy · Report an error on this page