ASSURE WCD SystemRecalls & reported problems across all models

We found 3 models of ASSURE WCD System by Kestra Medical Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 1,271 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2022 and Sep 30, 2026 — classified as 49 deaths, 5 injuries, 1,217 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (636 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

Most reported ASSURE WCD System problems

ASSURE WCD System models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ASSURE WCD System 80014-002

  Wearable Automated External Defibrillator
  31 deaths930 reports
• ASSURE WCD System 80014-003

  Wearable Automated External Defibrillator
  8 deaths179 reports
• ASSURE WCD System 80014-001

  Wearable Automated External Defibrillator
  10 deaths162 reports

Recent ASSURE WCD System adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  Shock delivered notification was received on the Customer Support Helpline queue. Customer care spoke with patient who confirmed therapeutic shock and stated they felt fine. Patient heard the device go off but didn't get to divert the alert on time. After the shock patient felt fatigued but is overall feeling fine now. Re-educated patient on canceling the shock by pressing the alert button. 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 50947412 ↗
• 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, 2026Inappropriate/Inadequate Shock/Stimulation; Use of Device Problem

  Patient called in to report a Service error code that can occur intermittently. Patient did not report gel being released and issue was initially resolved after reboot. Following evaluation of the returned device 09/09/2026, it was determined that gel was released and inappropriate therapeutic shock was delivered. Returned Monitor passed all evaluation tests. Returned Therapy cable could not be tested due to shock delivery and gel deployment which confirms that the Therapy Cable functioned as expected. There was no observed damage, and all gel was deployed during the event. Evaluation evidence indicates WCD performed per prescription and intended use. Carestation episode record indicates noise contributed to the therapeutic shock. Patient was fit and trained prior to initial use, including the use of the heart alert button to cancel the shock. However, patient heard the alert but did not cancel the shock using the WCD Heart Alert button.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869453 ↗
• 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; Failure to Power Up

  Patient reported getting service error code and when troubleshooting the monitor failed to power up. WCD role in the event is pending evaluation of to-be-returned device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869450 ↗