ZOLL LifeVestRecalls & reported problems across all models
Zoll Manufacturing Corporation · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 74,741
- Deaths reported
- 2,110
- Injuries reported
- 19,173
- Recalls
- 0
We found 10 models of ZOLL LifeVest by Zoll Manufacturing Corporation in the FDA's device registry (GUDID). Together they are named in 74,741 adverse event reports in the FDA's MAUDE database, received between Jun 9, 2017 and Sep 30, 2026 — classified as 2,110 deaths, 19,173 injuries, 53,457 malfunctions.
The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (7,408 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ZOLL LifeVest problems
Device problems
- Inappropriate/Inadequate Shock/Stimulation7,408
- Battery Problem6,943
- Failure to Power Up6,297
- Device Displays Incorrect Message5,362
- Circuit Failure4,945
- Break4,142
- Adverse Event Without Identified Device or Use Problem4,101
- Patient Device Interaction Problem3,534
Patient problems
- No Known Impact Or Consequence To Patient23,262
- No Clinical Signs, Symptoms or Conditions19,381
- Insufficient Information10,340
- Skin Inflammation/ Irritation6,010
- Shock from Patient Lead(s)5,459
- Arrhythmia4,034
- Skin Irritation2,870
- Death1,335
ZOLL LifeVest models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LifeVest Wearable Defibrillator LifeVest 4000 MonitorWearable Automated External Defibrillator2,039 deaths36,128 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Electrode BeltWearable Automated External Defibrillator44 deaths15,404 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery PackWearable Automated External Defibrillator1 death9,929 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery ChargerWearable Automated External Defibrillator1 death6,327 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Electrode BeltWearable Automated External Defibrillator14 deaths4,460 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery ChargerWearable Automated External Defibrillator1 death1,296 reports
- LifeVest Wearable Defibrillator LifeVest 5100 Battery PackWearable Automated External Defibrillator557 reports
- LifeVest Wearable Defibrillator LifeVest 5100 MonitorWearable Automated External Defibrillator9 deaths482 reports
- LifeVest Wearable Defibrillator LifeVest 5100 Electrode BeltWearable Automated External Defibrillator1 death114 reports
- LifeVest Wearable Defibrillator LifeVest 5100 Battery ChargerWearable Automated External Defibrillator44 reports
Recent ZOLL LifeVest adverse event reports
The 15 most recent reports across all models, 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, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951297 ↗MalfunctionSep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951150 ↗MalfunctionSep 30, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950793 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950660 ↗MalfunctionSep 30, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950547 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950502 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950290 ↗MalfunctionSep 30, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950072 ↗MalfunctionSep 30, 2026Battery Problem
A US distributor reported that a battery was unable to power on a monitor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949904 ↗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 ↗
Other Zoll Manufacturing Corporation products
All Zoll Manufacturing Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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