LifeVest Wearable Defibrillator LifeVest 4000 Electrode Belt (REF 10A1025)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 4000 is a wearable defibrillator with an electrode belt. Its 4,299 adverse event reports mostly describe circuit failures, broken or structurally damaged parts and incorrect messages on the display, and some describe the belt or monitor becoming unusable. The reports include 15 deaths and 274 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
- 4,460
- Deaths reported
- 14
- Injuries reported
- 317
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,460 adverse event reports that list this exact device (DI 00855778005135), received between Jun 14, 2017 and Sep 30, 2026 — classified as 14 deaths, 317 injuries, 4,129 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (1,846 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
- Circuit Failure1,846
- Structural Problem495
- Protective Measures Problem303
- Device Displays Incorrect Message247
- Break233
- Incorrect Interpretation of Signal189
- Display or Visual Feedback Problem171
- Defective Component148
Patient problems
- No Clinical Signs, Symptoms or Conditions2,610
- No Known Impact Or Consequence To Patient878
- Insufficient Information620
- Arrhythmia331
- Skin Inflammation/ Irritation10
- Death8
- No Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 4,460 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Over-Sensing
A patient received 2 inappropriate shocks. Motion artifact contributed to the false detection. The response buttons were not pressed during the event. The patient was at the facility at time of treatment. the patient did continue use of lifevest. No injury was reported,
Patient problems: Arrhythmia
MAUDE report 50945465 ↗InjurySep 30, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. SVT contributed to the false detection. The response buttons were not pressed during the event.The patient continues to use lifevest and was in the hospital at the time of treatment. No injury was reported
Patient problems: Arrhythmia
MAUDE report 50945117 ↗InjurySep 30, 2026Over-Sensing
A patient received two inappropriate shocks. Motion artifact contributed to the false detection. The response buttons were not pressed during the event.The patient was taken to the hospital for further evaluation. The patient did continue use of lifevest. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50945018 ↗InjurySep 29, 2026Over-Sensing
A patient received an inappropriate shock. Artifact contributed to the false detection. The response buttons were pressed after treatment.The patient continues wearing LifeVest. The patient was at the hospital at the time of treatment. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50935880 ↗InjurySep 29, 2026Over-Sensing
A patient received an inappropriate shock. Motion artifact contributed to the false detection. The response buttons were pressed during the event.The patient went to the hospital for further evaluation. The patient did continue use of lifevest. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50935702 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. SVT contributed to the false detection. The response buttons were not pressed during the event. The patient continues to wear lifevest. It is unknown if patient sought medical attention. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50935613 ↗InjurySep 29, 2026Over-Sensing
A patient received an inappropriate shock. Oversensing of low amplitude cardiac signal and motion artifact contributed to the false detection. The response buttons were pressed after the event.The patient continues wearing LifeVest. It is unknown if patient sought medical attention. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50935409 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. AF with RVR contributed to the false detection. The response buttons were not pressed during the event.The patient continues wearing LifeVest. The patient was at the hospital at the time of treatment. No injury was reported
Patient problems: Arrhythmia
MAUDE report 50934648 ↗MalfunctionSep 29, 2026Structural Problem
A US distributor reported that an electrode belt cannot run detect and treat testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934059 ↗MalfunctionSep 29, 2026Circuit Failure
A US distributor reported that a patient was experiencing check therapy electrode messages.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933968 ↗MalfunctionSep 29, 2026Structural Problem
A US distributor reported that an electrode belt does not communicate with a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933884 ↗InjurySep 29, 2026Over-Sensing
A patient received an inappropriate shock. AF with RVR and motion artifact contributed to the false detection. The response buttons were not pressed during the event.The patient went to the hospital for further evaluation and continues to wear the LifeVest. No injury was reported
Patient problems: Arrhythmia
MAUDE report 50933828 ↗MalfunctionSep 29, 2026Structural Problem
A US distributor reported that an electrode belt connector latch does not secure with monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933807 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. AF with RVR contributed to the false detection. The response buttons were not pressed during the event. The patient did continue use of lifevest. It is unknown if patient sought medical attention. No injury was reported
Patient problems: Arrhythmia
MAUDE report 50932989 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. AF with RVR contributed to the false detection. The response buttons were pressed during the event.The patient continues wearing LifeVest. It is unknown if patient sought medical attention. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50932358 ↗InjurySep 29, 2026Over-Sensing
A patient received an inappropriate shock. Motion artifact contributed to the false detection. The response buttons were not pressed during the event.The patient continues wearing LifeVest. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50931943 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. Oversensing of low amplitude cardiac signal contributed to the false detection. The response buttons were pressed after the event. The patient did continue use of lifevest. It is unknown if patient sought medical attention. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50931575 ↗MalfunctionSep 29, 2026Circuit Failure
A US distributor reported that a patient's electrode belt could not run detect and treat testing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931273 ↗MalfunctionSep 29, 2026Circuit Failure
A US distributor reported that an electrode belt had non-functional ECGs.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930993 ↗MalfunctionSep 29, 2026Structural Problem
A US distributor reported that an electrode belt had non-functional therapy electrodes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930915 ↗MalfunctionSep 29, 2026Structural Problem
A US distributor reported that an electrode belt had non-functional therapy electrodes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930904 ↗InjurySep 29, 2026Over-Sensing
A patient received an inappropriate shock. Motion artifact contributed to the false detection. The response buttons were not pressed during the event.The patient went to the hospital for further evaluation and continues to wear the LifeVest. No injury was reported
Patient problems: Arrhythmia
MAUDE report 50930901 ↗MalfunctionSep 29, 2026Structural Problem
A US distributor reported that an electrode belt had non-functional therapy electrodes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930885 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. Self-converting VT contributed to the false detection. The response buttons were not pressed during the event.The patient continues wearing the LifeVest. The patient was at the hospital at time of event. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50930798 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. SVT contributed to the false detection. The response buttons were pressed during the event.The patient continues to use lifevest. It is unknown if patient sought medical attention. No injury was reported.
Patient problems: Arrhythmia
MAUDE report 50930539 ↗
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 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