LifeVest Wearable Defibrillator LifeVest 5100 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 ZOLL LifeVest wearable defibrillator has 437 adverse event reports, with 223 injuries and 9 deaths. The reports mostly describe communication and transmission problems, unresponsive buttons, circuit failures and patient interaction issues, while many injury reports describe skin rashes and irritation under the vest. There were 410 reports in the last 12 months, up from 20 in the 12 months before. 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
- 482
- Deaths reported
- 9
- Injuries reported
- 246
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 482 adverse event reports that list this exact device (DI 00855778005371), received between Oct 1, 2024 and Sep 30, 2026 — classified as 9 deaths, 246 injuries, 227 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (155 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
- Patient Device Interaction Problem155
- Communication or Transmission Problem114
- Incorrect Interpretation of Signal66
- Circuit Failure64
- Key or Button Unresponsive/not Working49
- No Apparent Adverse Event36
- Over-Sensing29
- Contamination /Decontamination Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions228
- Skin Inflammation/ Irritation154
- Arrhythmia98
- Asystole1
- Contact Dermatitis1
- Head Injury1
Recent adverse event reports
The 25 most recent of 482 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Incorrect Interpretation of Signal
A patient received 2 inappropriate shocks.SVT contributed to the false detection.The response buttons were pressed during the event.The patient continues wearing LifeVest.
Patient problems: Arrhythmia
MAUDE report 50943672 ↗InjurySep 29, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed a rash under the LifeVest equipment. Patient described the area as pink spots on the back. The patient also reported having a known history of rosacea and Grover¿s disease. There was no alleged device malfunction contributing to the rash. There is no indication that the patient received medical intervention. The patient¿s physician prescribed Triomocycle cream and clindamycin foam for the rash. Follow up indicated that the rash improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50936689 ↗InjurySep 29, 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 an itchy, blotchy area on the skin along the right rib region.There was no alleged device malfunction contributing to the irritation. The patient¿s physician recommended a cream called Remedy for the skin irritation. Follow up indicated that the skin irritation improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50932210 ↗InjurySep 29, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed a skin irritation under the LifeVest equipment. The patient¿s nurse described the area as red, raw, burning and itching under the right breast area, and the garment digging into the skin. There was no alleged device malfunction contributing to the irritation. It's unclear if the nurse who spoke with support services applied any creams or ointments to the skin irritation. Follow up indicated that the skin irritation improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50931334 ↗InjurySep 29, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed an open wound under the LifeVest equipment. Patient described the area as an open rash/sore from neck to back. There was no alleged device malfunction contributing to the wound. The patient¿s home health nurse has been treating the area. Follow up indicated that the wound improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50931200 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. SVT contributed to the false detection. The response buttons were pressed after the event.The patient went to the hospital for further evaluation and was discharged home. Patient continues to wear the LifeVest.
Patient problems: Arrhythmia
MAUDE report 50930081 ↗InjurySep 29, 2026Incorrect Interpretation of Signal
A patient received 22 inappropriate shocks.AF with RVR contributed to the false detection.The response buttons were pressed during the event.Planned finished use.
Patient problems: Arrhythmia
MAUDE report 50929983 ↗InjurySep 28, 2026Incorrect Interpretation of Signal
The patient was appropriately treated by the LifeVest during VF. Post shock rhythm was Asystole with intermittent cardiac activity. Post shock asystole is a known and potentially adverse outcome of defibrillation therapy. The patient's neurological status at the time of the event is unknown. The patient went to the hospital for evaluation. The patient continues to use lifevest. No injury was reported,
Patient problems: Arrhythmia
MAUDE report 50917336 ↗InjurySep 25, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed an open wound under the LifeVest equipment. Patient described the area as a red and itchy blister that is leaking fluid. There was no alleged device malfunction contributing to the irritation. There is no indication that the patient received medical intervention. Outcome of the irritation is unknown as follow up attempts were unsuccessful.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50898550 ↗InjurySep 25, 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 sore and irritated rash under both breast areas. There was no alleged device malfunction contributing to the irritation. The patient¿s physician prescribed an unscented anti-fungal cream for the skin irritation. Follow up indicated that the skin irritation improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50897102 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
The reported problem (injury) was confirmed. A US distributor reported that a patient bent over and the monitor fell from their shoulder and hit them on the temple, causing an extended headache. There is no indication that the patient received medical intervention. Outcome of the headache is unknown.
Patient problems: Head Injury
MAUDE report 50897006 ↗InjurySep 23, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50876428 ↗MalfunctionSep 23, 2026Circuit Failure
A US distributor returned a monitor and reported monitor does not power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866272 ↗MalfunctionSep 23, 2026Circuit Failure
A US distributor returned a monitor and reported monitor does not power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866222 ↗MalfunctionSep 23, 2026Circuit Failure
A US distributor returned a monitor a blank screen and it would not power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866174 ↗InjurySep 22, 2026Incorrect Interpretation of Signal
A patient received an inappropriate shock. Double counting 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.
Patient problems: Arrhythmia
MAUDE report 50858927 ↗MalfunctionSep 22, 2026Circuit Failure
A US distributor returned a monitor and reported monitor was displaying a service code.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858776 ↗MalfunctionSep 22, 2026Circuit Failure
A US distributor returned a monitor and reported monitor was displaying a service code and adjust belt messages.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857601 ↗MalfunctionSep 21, 2026Communication or Transmission Problem
A US distributor returned a monitor and reported displaying a service code indicating a potential device malfunction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838316 ↗MalfunctionSep 21, 2026Communication or Transmission Problem
A US distributor returned a monitor and reported displaying a service code indicating a potential device malfunction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838218 ↗MalfunctionSep 17, 2026Circuit Failure
A US distributor reported that a monitor's alarms or messages were not audible.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807596 ↗InjurySep 17, 2026Patient Device Interaction Problem
A US distributor contacted ZOLL to report that a patient developed blisters under the LifeVest equipment. There was no alleged device malfunction contributing to the irritation. The patient¿s physician recommended seeing a dermatologist for the skin irritation. Follow up indicated that the skin irritation improved.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50803524 ↗InjurySep 16, 2026Patient Device Interaction Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50794415 ↗MalfunctionSep 16, 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 50791265 ↗MalfunctionSep 16, 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 50790245 ↗
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
- 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
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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