ASSURE WCD System 80014-003Recalls & reported problems
Kestra Medical Technologies, Inc. · The ASSURE Wearable Cardioverter Defibrillator System · Class 3
All models of ASSURE WCD System (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Kestra ASSURE wearable defibrillator has 120 adverse event reports, with 4 deaths and no injuries. Reports mostly describe electrical problems, inappropriate shocks and failures to power up or charge, along with service error codes. Reports rose from 0 in the prior 12 months to 120 in the last 12 months. According to the manufacturer, the device's role in the deaths is still pending evaluation.
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
- 179
- Deaths reported
- 8
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00840241600375), received between May 6, 2026 and Sep 30, 2026 — classified as 8 deaths, 171 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (130 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, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem130
- Inappropriate/Inadequate Shock/Stimulation33
- Failure to Power Up9
- Adverse Event Without Identified Device or Use Problem8
- Failure to Charge2
Patient problems
- No Clinical Signs, Symptoms or Conditions171
- Insufficient Information7
- Heart Failure/Congestive Heart Failure1
Recent adverse event reports
The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation
Shock delivered notification was received on the Customer Support Helpline queue. At first the patient said they just recently received the shock, then wasn't sure about the exact time of the event. Patient stated that the shock occured while walking to their bed. The reported injury was not life-threatening, did not result in permanent damage, or necessitate medical intervention to preclude permanent damage.WCD role in the shock event is pending additional medical information and pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947416 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947415 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947413 ↗DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient's caregiver reported that the patient had expired and does not know where the WCD system is. No other details were provided. MDR filed due to reported patient death possibly while wearing the device. WCD role in patient death is pending additional medical information and pending evaluation of to-be-returned device.
Patient problems: Insufficient Information
MAUDE report 50947411 ↗MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947410 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient reported "Connect the plug" prompts while the Therapy cable is plugged in and Service error code. No success troubleshooting. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947409 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947408 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947407 ↗MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947406 ↗MalfunctionSep 23, 2026Electrical /Electronic Property Problem
Patient reports multiple service error codes. No success troubleshooting. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869462 ↗DeathSep 23, 2026Adverse Event Without Identified Device or Use Problem
Hospital emergency room reported patient deceased on (b)(6) 2026. Patient was in Assisted living and EMS was called due to patient being unresponsive. Patient had also received a therapeutic shock. Device episode reported indicated patient had 3 tachycardia untreated episodes, 1 therapy diverted epiode, 1 Tachy treated epsiode followed by a final asystole episode. MDR filed due to reported patient death while wearing the device. WCD role in patient death is pending additional medical information and pending evaluation of to-be-returned device.
Patient problems: Insufficient Information
MAUDE report 50869460 ↗MalfunctionSep 23, 2026Electrical /Electronic Property Problem
Patient called in with service code on monitor. No success troubleshooting. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869451 ↗MalfunctionSep 23, 2026Electrical /Electronic Property Problem
Patient reports service error code.No success troubleshooting. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869448 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient is getting service error code. All troubleshooting was exhausted. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855963 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient received multiple Service error codes. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855960 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient reported Service error code and "Connect the Plug to Your Monitor" alerts. No success troubleshooting. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855957 ↗MalfunctionSep 22, 2026Inappropriate/Inadequate Shock/Stimulation
Shock delivered notification was received on the Customer Support Helpline queue. EMS was dispatched. The reported injury was not life-threatening, did not result in permanent damage, or necessitate medical intervention to preclude permanent damage. WCD role in the shock event is pending additional medical information and pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855948 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient reported getting Service error code and wrench on monitor. Attempted to troubleshoot but patient got "connect your plug to alerts" even though therapy cable was plugged in. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855945 ↗MalfunctionSep 22, 2026Inappropriate/Inadequate Shock/Stimulation
Shock delivered notification was received on the Customer Support Helpline queue. EMS was dispatched. The reported injury was not life-threatening, did not result in permanent damage, or necessitate medical intervention to preclude permanent damage. WCD role in the shock event is pending additional medical information and pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855943 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient reported Service error code. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855941 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient reported Service Error code. No success troubleshooting.WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855938 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient reported Service error code. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855933 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
KMTS field rep called to report mutliple occurences of Service error code and "connect plug to monitor" alerts. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855931 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem; Failure to Power Up
Patient's caregiver reported of multiple Service error code and Monitor failed to bootup. WCD role in the event is pending evaluation of to-be-returned device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855920 ↗MalfunctionSep 16, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788899 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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