ASSURE WCD System 80014-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 00840241600047), received between Mar 2, 2022 and Nov 19, 2025 — classified as 10 deaths, 2 injuries, 150 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (96 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Inappropriate/Inadequate Shock/Stimulation; Use of Device Problem; Inappropriate/Inadequate Shock/Stimulation; Use of Device Problem

  PATIENT'S DOCTOR FROM ER REPORTED PATIENT ARRIVED VIA AMBULANCE AND STATED THEY RECEIVED THERAPEUTIC SHOCK THREE TIMES. THE REPORTED INJURY WAS NOT LIFE-THREATENING, DID NOT RESULT IN PERMANENT DAMAGE, OR NECESSITATE MEDICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE. HOWEVER, AN UNDIVERTED SHOCK TO A CONSCIOUS PATIENT COULD RESULT IN SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596142 ↗
• MalfunctionJul 16, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PATIENT CALLED IN TO REPORT SERVICE ERROR CODE WITH WRENCH APPEARING ON MONITOR SCREEN. PATIENT REBOOTED THE ENTIRE WCD SYSTEM BUT THE ISSUE WAS NOT RESOLVED. THE UNRESOLVABLE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750557 ↗
• MalfunctionJan 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. PATIENT CONFIRMED RECEIVING A WRENCH ICON. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499533 ↗
• MalfunctionJan 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18471037 ↗
• MalfunctionNov 30, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PATIENT CALLED IN TO REPORT THAT IT ALERTED THE PATIENT TO "CALL THE HELPLINE, YOUR OUR DEVICE NEEDS SERVICE." THE PATIENT STATED THAT THERE IS A WRENCH ON THE MONITOR WITH THE SERVICE ERROR CODE. CUSTOMER CARE ADVISED THE PATIENT TO REBOOT THE SYSTEM. THE ISSUE WAS RESOLVED. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238474 ↗
• MalfunctionNov 7, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085883 ↗
• MalfunctionNov 4, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  CUSTOMER SUPPORT RECEIVED A SERVICE REQUIRED CODE FROM A CALL BY PATIENT'S FAMILY CAREGIVER THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070338 ↗
• MalfunctionNov 4, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  CUSTOMER SUPPORT RECEIVED A SERVICE REQUIRED CODE ON THE HELPLINE QUEUE. CUSTOMER SUPPORT CONFIRMED THE PATIENT IS UNABLE TO REBOOT THE SYSTEM WITHOUT REGENERATING THE SERVICE CODE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070301 ↗
• MalfunctionNov 4, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  CUSTOMER SUPPORT RECEIVED A SERVICE REQUIRED CODE ON THE HELPLINE QUEUE CUSTOMER SUPPORT WAS ABLE TO CONFIRM THE PATIENT CLEARED THE CODE BY RE-BOOTING THE DEVICE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070289 ↗
• MalfunctionOct 23, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986198 ↗
• MalfunctionOct 16, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946920 ↗
• MalfunctionOct 16, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946890 ↗
• MalfunctionOct 16, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946884 ↗
• MalfunctionOct 16, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946881 ↗
• MalfunctionOct 10, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909631 ↗
• MalfunctionOct 10, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908833 ↗
• MalfunctionOct 3, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  PATIENT RECEIVED A THERAPEUTIC SHOCK WHILE WEARING THE WCD IN HOSPITAL FOLLOWING AN UNRELATED SURGERY. SPOUSE REPORTED THE PATIENT WAS LIGHTLY SEDATED AND RESTRAINED WHILE ON A VENTILATOR AND UNABLE TO DIVERT THE SHOCK. SPOUSE REPORTED THAT NURSES WERE INDEPENDENTLY AWARE OF PATIENT'S HIGH HEART RATE OVER AN EXTENDED PERIOD OF TIME BUT WOULD NOT HAVE SHOCKED THE PATIENT. CUSTOMER CARE ADVISED THE PATIENT'S SPOUSE THAT THE WCD IS NOT INTENDED FOR IN-HOSPITAL USE AND ADVISED THE SPOUSE SPEAK TO PATIENT'S HEALTHCARE PROVIDER ABOUT REMOVING THE SYSTEM.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17865670 ↗
• MalfunctionSep 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821957 ↗
• MalfunctionSep 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821504 ↗
• MalfunctionSep 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821503 ↗
• MalfunctionSep 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769794 ↗
• MalfunctionSep 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  CUSTOMER CARE RECEIVED A SERVICE REQUIRED NOTIFICATION ON THE HELPLINE QUEUE. CUSTOMER CARE CALLED THE PATIENT WHO SAID HE RECEIVED TWO ALERTS. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769775 ↗
• DeathSep 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT'S FRIEND STEPPED OUT OF THE ROOM TO GET SOME ICE AND ON RETURN THE PATIENT WAS FOUND UNRESPONSIVE. WHEN ASKED IF A FAMILY MEMBER KNEW WHETHER THE PATIENT WAS WEARING THE WCD AT THE TIME, THE ANSWER WAS AFFIRMATIVE. THE WCD WAS CUT OFF THE PATIENT BY THE PERSONS THAT RESPONDED TO THE 911 CALL -- AND THE RESPONDERS DISPOSED OF THE WCD. THE FAMILY MEMBER REPORTED CAUSE OF DEATH AS CONGESTIVE HEART FAILURE. BECAUSE THE WCD WAS DESTROYED, THE PATIENT'S EVENT LOGS AND EPISODE REPORTS ARE NOT AVAILABLE FOR FURTHER INVESTIGATION..

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17751295 ↗
• MalfunctionSep 14, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A SERVICE REQUIRED CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THE SERVICE CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750820 ↗
• MalfunctionSep 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SERVICE ERROR CODE WAS RECEIVED ON THE CUSTOMER SUPPORT HELPLINE QUEUE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. HOWEVER, THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741450 ↗