LifeVest Wearable Defibrillator LifeVest 4000 MonitorRecalls & 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 is a ZOLL LifeVest wearable defibrillator. Its reports mostly describe shocks that were inappropriate or inadequate, skin irritation under the vest, unresponsive buttons and broken parts. There are 35,824 reports, including 2,032 deaths and 17,704 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
- 36,128
- Deaths reported
- 2,039
- Injuries reported
- 17,887
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36,128 adverse event reports that list this exact device (DI 00855778005005), received between Jun 14, 2017 and Sep 30, 2026 — classified as 2,039 deaths, 17,887 injuries, 16,201 malfunctions.
The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (7,365 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
- Inappropriate/Inadequate Shock/Stimulation7,365
- Adverse Event Without Identified Device or Use Problem3,973
- Patient Device Interaction Problem3,356
- Signal Artifact/Noise2,928
- Break2,035
- Key or Button Unresponsive/not Working1,980
- Over-Sensing1,838
- Incorrect Interpretation of Signal1,837
Patient problems
- No Known Impact Or Consequence To Patient7,123
- Skin Inflammation/ Irritation5,798
- Shock from Patient Lead(s)5,432
- No Clinical Signs, Symptoms or Conditions5,290
- Insufficient Information3,535
- Arrhythmia3,403
- Skin Irritation2,681
- Death1,242
Recent adverse event reports
The 25 most recent of 36,128 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951297 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949685 ↗InjurySep 30, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50949645 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949556 ↗InjurySep 30, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50949525 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949374 ↗InjurySep 30, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50949335 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949043 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948972 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948881 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948730 ↗InjurySep 30, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed a skin irritation under the LifeVest equipment. Patient described the area as a red and itchy skin irritation on the back. There was no alleged device malfunction contributing to the irritation. The patient reported being seen by the doctor at the hospital, but there is no indication of medical intervention specifically for the skin irritation. Follow up indicated that the skin irritation improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50947947 ↗MalfunctionSep 30, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947393 ↗InjurySep 30, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed a skin irritation under the LifeVest equipment. Patient described the area as a rash under the shoulder straps and garment. The patient also reported a history of skin sensitivity or allergies, and lupus. There was no alleged device malfunction contributing to the irritation. The patient¿s dermatologist prescribed a medication for the skin irritation. Outcome of the irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50947306 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947286 ↗MalfunctionSep 30, 2026Key or Button Unresponsive/not Working
A US distributor reported that a monitor's response buttons were not functioning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946985 ↗MalfunctionSep 30, 2026Circuit Failure
A US distributor returned a monitor and reported being unable to complete incoming functional testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945840 ↗InjurySep 30, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed a skin irritation under the LifeVest equipment. Patient described the area as swollen and red from the garment clip rubbing up against the chest. The patient also reported having had a mastectomy which makes the garment lay in a different way which can be contributing to the irritation. There was no alleged device malfunction contributing to the irritation. The patient reported being in a rehabilitation facility, but there is no indication of medical intervention specifically for the skin irritation. Outcome of the irritation is unknown as follow up attempts were unsuccessful.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50945727 ↗MalfunctionSep 30, 2026Circuit Failure
A US distributor returned a monitor and reported being unable to complete incoming functional testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945679 ↗InjurySep 30, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed a skin irritation under the LifeVest equipment. There was no alleged device malfunction contributing to the irritation. The patient¿s physician prescribed a Nystatin cream for the skin irritation. Outcome of the irritation is unknown.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50945645 ↗MalfunctionSep 30, 2026Circuit Failure
A US distributor returned a monitor and reported being unable to complete incoming functional testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945566 ↗MalfunctionSep 30, 2026Circuit Failure
A US distributor returned a monitor and reported being unable to complete incoming functional testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945345 ↗InjurySep 30, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed a skin irritation under the LifeVest equipment. Patient described the area as a heat rash all over the LifeVest. The patient also reported to stop wearing LifeVest until the skin irritation is healed. There was no alleged device malfunction contributing to the irritation. The patient¿s physician prescribed a cream for the skin irritation. Follow up indicated that the skin irritation improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50945111 ↗InjurySep 30, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed an allergic reaction under the LifeVest equipment. Patient described the area as red and bumpy under the back TE pads. The patient¿s physician confirmed they had an allergic reaction to nickel. There was no alleged device malfunction contributing to reaction. The patient¿s physician prescribed a steroid cream for the reaction. Follow up indicated that the reaction improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50944737 ↗InjurySep 30, 2026Incorrect Interpretation of Signal
A patient received 2 inappropriate shocks. AF with RVR contributed to the false detection. The response buttons were pressed after the event.The patient continues wearing LifeVest.
Patient problems: Arrhythmia
MAUDE report 50943698 ↗
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 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
- 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