LifeVest Wearable Defibrillator LifeVest 4000 Battery Charger (REF 10A0985)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 to charge the batteries of a wearable defibrillator. Of its 6,275 reports, 1 describes a death and 186 describe injuries; many describe charging problems, failures to power up and unexpected resets. Recent reports, from a US distributor, describe chargers that keep resetting or do not recognize batteries. 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: 6,327
Deaths reported: 1
Injuries reported: 186
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6,327 adverse event reports that list this exact device (DI 00855778005029), received between Jun 13, 2017 and Sep 30, 2026 — classified as 1 death, 186 injuries, 6,140 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (1,889 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Charging Problem1,889
Failure to Charge1,522
Failure to Power Up1,370
Reset Problem313
Inappropriate or Unexpected Reset267
Contamination /Decontamination Problem206
Battery Problem193
Device Displays Incorrect Message175

Patient problems

No Known Impact Or Consequence To Patient3,566
No Clinical Signs, Symptoms or Conditions1,643
Insufficient Information1,014
No Information94
No Patient Involvement4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Death1
Erythema1

Recent adverse event reports

The 25 most recent of 6,327 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951341 ↗
MalfunctionSep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951150 ↗
MalfunctionSep 30, 2026Charging Problem
A US distributor reported that a battery charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948322 ↗
MalfunctionSep 30, 2026Charging Problem
A US distributor reported that a battery charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947113 ↗
MalfunctionSep 30, 2026Charging Problem
A US distributor reported that a battery charger was resetting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946875 ↗
MalfunctionSep 30, 2026Charging Problem
A US distributor reported that a battery charger was resetting.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946781 ↗
MalfunctionSep 29, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938389 ↗
MalfunctionSep 29, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938316 ↗
MalfunctionSep 29, 2026Charging Problem; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938098 ↗
MalfunctionSep 29, 2026Charging Problem; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937989 ↗
MalfunctionSep 29, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937752 ↗
MalfunctionSep 29, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937675 ↗
MalfunctionSep 29, 2026Contamination /Decontamination Problem
A US distributor reported that a battery charger was unable to charge a battery pack.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931259 ↗
MalfunctionSep 29, 2026Charging Problem
A US distributor reported that a battery charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931164 ↗
MalfunctionSep 28, 2026Charging Problem
A US distributor reported that a battery charger was displaying an error code when charging a battery pack.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913416 ↗
MalfunctionSep 28, 2026Battery Problem; Charging Problem
A US distributor reported that a battery charger was having temperature issues and was unable to recognize a battery pack.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913335 ↗
MalfunctionSep 28, 2026Charging Problem
A US distributor reported that a battery charger had a battery charger problem.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913124 ↗
MalfunctionSep 28, 2026Charging Problem
A US distributor reported that a battery charger had a battery charger connector problem.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912950 ↗
MalfunctionSep 25, 2026Charging Problem
A US distributor reported that a battery charger had a battery charger problem.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898615 ↗
MalfunctionSep 25, 2026Charging Problem
A US distributor reported that a battery charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898537 ↗
MalfunctionSep 25, 2026Charging Problem
A US distributor reported that a battery charger was unable to charge a battery pack.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896458 ↗
MalfunctionSep 25, 2026Charging Problem
A US distributor reported that a battery charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896384 ↗
MalfunctionSep 25, 2026Charging Problem
A US distributor reported that a battery charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896372 ↗
MalfunctionSep 25, 2026Charging Problem
A US distributor reported that a battery charger had battery/charger faults.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896337 ↗
MalfunctionSep 25, 2026Charging Problem
A US distributor reported that a battery charger was unable to power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896298 ↗

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 · Terminated
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
Z-0625-2011 · Sep 24, 2010 · Terminated
Model 4000 Monitor component of the LifeVest Wearable Defibrillator
Z-0883-2009 · Oct 21, 2008 · Terminated
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
Z-0061-2008 · Sep 14, 2007 · Terminated
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).
Z-0936-2007 · Apr 27, 2007 · Terminated
Electrode 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 · Terminated
Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.

Device details

UDI-DI	`00855778005029`
Brand	LifeVest Wearable Defibrillator
Model	LifeVest 4000 Battery Charger
Catalog no.	10A0985
Company	Zoll Manufacturing Corporation
Product code	MVK · Wearable Automated External Defibrillator
Class	Class 3
FDA submission	P010030
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Mar 20, 2025

Device type (GMDN): Wearable defibrillation system

An assembly of devices worn by a patient to continuously monitor the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and to defibrillate the heart (restore normal rhythm) with electrical shocks. Monitoring is performed with dry, non-adhesive electrodes and the patient is alerted by the device prior to electrical shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the system releases gel over the electrodes and delivers a shock. The system consists of a wearable vest containing the electrodes and a portable defibrillator carried by the patient.

Other Wearable Automated External Defibrillator devices

LifeVest Wearable Defibrillator LifeVest 4000 Monitor
Zoll Manufacturing Corporation · Wearable Automated External Defibrillator
2,039 deaths36,128 reports
LifeVest Wearable Defibrillator LifeVest 4000 Electrode Belt
Zoll Manufacturing Corporation · Wearable Automated External Defibrillator
44 deaths15,404 reports
LifeVest Wearable Defibrillator LifeVest 4000 Battery Pack
Zoll Manufacturing Corporation · Wearable Automated External Defibrillator
1 death9,929 reports
LifeVest Wearable Defibrillator LifeVest 4000 Electrode Belt
Zoll Manufacturing Corporation · Wearable Automated External Defibrillator
14 deaths4,460 reports
LifeVest Wearable Defibrillator LifeVest 4000 Battery Charger
Zoll Manufacturing Corporation · Wearable Automated External Defibrillator
1 death1,296 reports
ASSURE WCD System 80014-002
Kestra Medical Technologies, Inc. · Wearable Automated External Defibrillator
31 deaths930 reports
LifeVest Wearable Defibrillator LifeVest 5100 Battery Pack
Zoll Manufacturing Corporation · Wearable Automated External Defibrillator
557 reports
LifeVest Wearable Defibrillator LifeVest 5100 Monitor
Zoll Manufacturing Corporation · Wearable Automated External Defibrillator
9 deaths482 reports

All Wearable Automated External Defibrillator devices →

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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