LifeVest Wearable Defibrillator LifeVest 4000 Electrode Belt (REF 10A0987)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15,404 adverse event reports that list this exact device (DI 00855778005012), received between Jun 9, 2017 and Sep 30, 2026 — classified as 44 deaths, 454 injuries, 14,906 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3,683 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 15,404 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Incorrect Interpretation of Signal

  :A patient received 2 inappropriate shocks. NSVT contributed to the false detection. The response buttons were not pressed during the event.The patient went to the hospital for further evaluation. The patient did not continue use of lifevest. No injury was reported

  Patient problems: Arrhythmia

  MAUDE report 50945517 ↗
• InjurySep 29, 2026Incorrect Interpretation of Signal

  Patient problems: Arrhythmia

  MAUDE report 50934722 ↗
• 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 50934153 ↗
• MalfunctionSep 29, 2026Circuit Failure

  A US distributor reported that a patient's electrode belt latch does not communicate with monitor.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934096 ↗
• InjurySep 29, 2026Over-Sensing

  The monitor and electrode belt have not been returned for evaluation. Based on the data available at this time, there is no indication of a device malfunction causing or contributing to the inappropriate treatment. Inappropriate defibrillations are an anticipated risk associated with the use of the LifeVest. Patients are instructed through alarms, voice messages, IFU, and training to press the response buttons to prevent an inappropriate defibrillation. The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4) (0.69% per patient-month with 90% confidence). A summary of the safety and effectiveness data (SSED), including the inappropriate defibrillation safety objective supporting FDA's approval of the LifeVest, can be found at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010030b.pdf.

  Patient problems: Arrhythmia

  MAUDE report 50930596 ↗
• InjurySep 28, 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 was at hospital at the time of event, and discontinued the use of the LifeVest. No injury was reported.

  Patient problems: Arrhythmia

  MAUDE report 50917817 ↗
• MalfunctionSep 28, 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 50917816 ↗
• MalfunctionSep 28, 2026Circuit Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917701 ↗
• MalfunctionSep 28, 2026Circuit Failure

  A US distributor reported that a patient was experiencing adjust belt and check pad messages.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916763 ↗
• MalfunctionSep 28, 2026Circuit Failure

  A US distributor reported that a belt was damaged and was experiencing adjust belt and check pad messages.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916517 ↗
• MalfunctionSep 22, 2026Structural Problem

  A US distributor reported that a patient was receiving adjust belt messages.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859267 ↗
• MalfunctionSep 21, 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 50843454 ↗
• MalfunctionSep 21, 2026Structural Problem

  A US distributor reported that a patient was experiencing check therapy electrode messages.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843218 ↗
• MalfunctionSep 21, 2026Structural Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841934 ↗
• MalfunctionSep 21, 2026Structural Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841914 ↗
• MalfunctionSep 21, 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 50841751 ↗
• MalfunctionSep 21, 2026Structural Problem

  A US Distributor contacted ZOLL to report that a patient was experiencing "add gel/replace belt" messages.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841505 ↗
• MalfunctionSep 21, 2026Structural Problem

  A US distributor reported that an electrode belt had non-functional ECGs.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841482 ↗
• MalfunctionSep 21, 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 50841284 ↗
• MalfunctionSep 21, 2026Structural Problem

  A US distributor reported an electrode belt cannot run detect and treat testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841122 ↗
• MalfunctionSep 21, 2026Structural Problem

  A US distributor reported that an electrode belt had non-functional ECGs.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841116 ↗
• MalfunctionSep 21, 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 50838020 ↗
• MalfunctionSep 18, 2026Circuit Failure

  A US distributor reported that an electrode belt had a damaged cable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820646 ↗
• MalfunctionSep 17, 2026Circuit Failure

  A US distributor reported that an electrode belt had non-functional ECGs.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802092 ↗
• MalfunctionSep 16, 2026Circuit Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793765 ↗

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.