ASSURE WCD System 80014-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 930 adverse event reports that list this exact device (DI 00840241600238), received between Aug 14, 2023 and Sep 30, 2026 — classified as 31 deaths, 3 injuries, 896 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (410 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 930 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. 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 ↗
• 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; 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 ↗
• MalfunctionSep 22, 2026Inappropriate/Inadequate Shock/Stimulation

  Shock delivered notification was received on the Customer Support Helpline queue. EMS was dispatched. Patient confirmed therapeutic shock but did not press alert button to divert shock. Patient got transported to Hospital ER for medical evaluation.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 50855954 ↗
• MalfunctionSep 22, 2026Electrical /Electronic Property Problem

  Patient reported Service error code. Patient further stated that they have been getting Service alert at night due to sress on Therapy cable. WCD role in the event is pending evaluation of to-be-returned device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855951 ↗
• MalfunctionSep 22, 2026Electrical /Electronic Property Problem

  Patient reported multiple occurences of 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 50855936 ↗
• MalfunctionSep 22, 2026Electrical /Electronic Property Problem

  Patient reports multiple service error codes.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855927 ↗
• MalfunctionSep 22, 2026Inappropriate/Inadequate Shock/Stimulation

  Shock delivered notification was received on the Customer Support Helpline queue. Customer care spoke with patient and the patient stated that they were not at home when shock occurred. Patient out of breath and had difficulty answering questions. Confirmed patient received therapeutic shock and did not press alert button to divert the shock. Patient further stated that the WCD system shocked the patient multiple times. Confirmed EMS called and ambulance arrived. Patient got transported to Hospital ER for medical evaluation. 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 50855924 ↗
• MalfunctionSep 16, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788901 ↗
• MalfunctionSep 16, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788900 ↗
• MalfunctionSep 15, 2026Electrical /Electronic Property Problem

  Patient has recurring Service code that does not clear. WCD role in the event is pending evaluation of to-be-returned device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775434 ↗
• MalfunctionSep 9, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694747 ↗
• MalfunctionSep 9, 2026Electrical /Electronic Property Problem

  Patient reports 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 50694652 ↗
• MalfunctionSep 9, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694651 ↗
• MalfunctionSep 2, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566532 ↗
• MalfunctionSep 1, 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 50545170 ↗
• DeathSep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient expired on (b)(6)2026. 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 50545169 ↗
• DeathAug 28, 2026Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  KMTS Field rep reported a shock delivered and patient death. It is not clear whether the shock occurred before death or after and no further information was available.

  Patient problems: Insufficient Information

  MAUDE report 50501680 ↗
• MalfunctionAug 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501673 ↗
• MalfunctionAug 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501670 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  Patient's spouse reports "device needs service" service code and "connect the plug to monitor" alert. WCD role in the event is pending evaluation of to-be-returned device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482726 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  Patient reported reoccurring 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 50482722 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem; Use of Device Problem

  Patient reported that their Therpy Cable was cut during work.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482717 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  Patient reports 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 50482716 ↗
• MalfunctionAug 27, 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 50482715 ↗