LifeVest Wearable Defibrillator LifeVest 5100 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 ZOLL LifeVest 5100 battery pack powers a wearable defibrillator. Its 553 reports almost all describe battery problems, and some describe bent pins found after patient fitting. Reports rose from 178 in the earlier 12 months to 363 in the latest 12 months. The reports include no deaths and no injuries. 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
- 557
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 557 adverse event reports that list this exact device (DI 00855778005401), received between Sep 30, 2024 and Sep 30, 2026 — classified as 557 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (550 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 Problem550
- Contamination /Decontamination Problem6
- Charging Problem3
- No Apparent Adverse Event3
- Circuit Failure1
- Patient Device Interaction Problem1
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions557
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 557 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945530 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945399 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified prior to patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945217 ↗MalfunctionSep 28, 2026Battery Problem; Contamination /Decontamination Problem
A US distributor reported that a battery pack has bent pins identified prior to patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917185 ↗MalfunctionSep 28, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916974 ↗MalfunctionSep 28, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified prior to patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916890 ↗MalfunctionSep 28, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916737 ↗MalfunctionSep 28, 2026Contamination /Decontamination Problem; No Apparent Adverse Event
A US distributor reported a battery was damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915443 ↗MalfunctionSep 28, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912835 ↗MalfunctionSep 23, 2026Battery Problem
A US distributor reported that a battery pack has bent pins.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871127 ↗MalfunctionSep 23, 2026Battery Problem
A US distributor reported that a battery pack has bent pins.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868142 ↗MalfunctionSep 18, 2026Battery Problem
A US distributor reported a battery pack had bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816779 ↗MalfunctionSep 18, 2026Battery Problem
A US distributor reported a battery pack had bent pins identified after patient fitting
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816718 ↗MalfunctionSep 18, 2026Battery Problem
A US distributor reported a battery pack had bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816660 ↗MalfunctionSep 11, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50730228 ↗MalfunctionAug 24, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412869 ↗MalfunctionAug 24, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412709 ↗MalfunctionAug 24, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412615 ↗MalfunctionAug 24, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410986 ↗MalfunctionAug 24, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410509 ↗MalfunctionAug 17, 2026Battery Problem
A US distributor reported a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50274299 ↗MalfunctionAug 14, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256424 ↗MalfunctionAug 10, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194223 ↗MalfunctionAug 10, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified after patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194156 ↗MalfunctionAug 10, 2026Battery Problem
A US distributor reported that a battery pack has bent pins identified prior to patient fitting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194035 ↗
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 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