LifeVest Wearable Defibrillator LifeVest 4000 Battery Charger (REF 10A1043)Recalls & 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 battery charger is used with a wearable defibrillator. Most reports describe the charger failing to charge or power on, and some describe contamination problems. The FDA database lists 1,282 reports, with 54 injuries and 1 death, and reports rose in the last 12 months, to 508 from 276. 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
- 1,296
- Deaths reported
- 1
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,296 adverse event reports that list this exact device (DI 00855778005210), received between Jun 29, 2017 and Sep 25, 2026 — classified as 1 death, 54 injuries, 1,241 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (746 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
- Charging Problem746
- Contamination /Decontamination Problem226
- Failure to Power Up124
- Failure to Charge103
- Battery Problem98
- Break16
- Defective Component14
- Therapeutic or Diagnostic Output Failure7
Patient problems
- No Clinical Signs, Symptoms or Conditions935
- Insufficient Information333
- No Known Impact Or Consequence To Patient27
- Death1
Recent adverse event reports
The 25 most recent of 1,296 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896180 ↗MalfunctionSep 25, 2026Contamination /Decontamination Problem
A US distributor reported that a charger was unable to charge a battery pack.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896169 ↗MalfunctionSep 25, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892678 ↗MalfunctionSep 25, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892640 ↗MalfunctionSep 25, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892630 ↗MalfunctionSep 25, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892615 ↗MalfunctionSep 25, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892571 ↗MalfunctionSep 25, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892543 ↗MalfunctionSep 25, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892492 ↗MalfunctionSep 24, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891108 ↗MalfunctionSep 24, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886602 ↗MalfunctionSep 24, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884654 ↗MalfunctionSep 24, 2026Charging Problem
A US distributor reported that a charger failed due to a functional issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884493 ↗MalfunctionSep 24, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884301 ↗MalfunctionSep 24, 2026Charging Problem
A US distributor reported that a charger had a battery charger problem.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883710 ↗MalfunctionSep 24, 2026Charging Problem
A US distributor reported that a charger had a battery charger problem.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883463 ↗MalfunctionSep 24, 2026Charging Problem; Contamination /Decontamination Problem
A US distributor reported that a charger failed due to a functional issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883385 ↗MalfunctionSep 24, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883319 ↗MalfunctionSep 10, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718492 ↗MalfunctionSep 10, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718450 ↗MalfunctionSep 10, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718419 ↗MalfunctionSep 10, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713413 ↗MalfunctionSep 10, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713332 ↗MalfunctionSep 10, 2026Charging Problem
A US distributor reported that a charger had a power connector problem.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713110 ↗MalfunctionSep 10, 2026Charging Problem
A US distributor reported that a charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712992 ↗
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
- 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.
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