Curaplex 16381Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815277023894), received between May 28, 2021 and May 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

11 other recalls cover devices cleared under the same FDA submission (K080421); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 CUSTOMER BOUNDTREE/ CURAPLEX EMAILED (B)(6) CUSTOMER SERVICE THE FOLLOWING REPORT OF COMPLAINT EVENT: ROBERTSON CO WAS WORKING A CARDIAC ARREST A COUPLE OF DAYS AGO AND WHEN THEY PRESSED THE "SHOCK" BUTTON ON THE DEFIBRILLATOR, SPARKS AND ARCING SHOT OUT FROM THE PADS AND APPARENTLY ALSO BURNED THE PATIENT. AS PER THE CHIEF OF THE FIRE DEPARTMENT, THE SEQUENCE HE DESCRIBED WAS AS FOLLOWS: MALE PATIENT PRESENTED IN CARDIAC ARREST DEFIB PADS APPLIED. FIRST SHOCK DELIVERED IN PT HOUSE WAS SUCCESSFUL. MOVED PT TO AMBULANCE SHOCKED AGAIN FOR SECOND TIME[ AND THIS IS THE SHOCK THAT PRODUCED THE SPARKS. HOWEVER, THE DEFIBRILLATION WAS SUCCESSFUL AND THEY ACHIEVED ROSC. DELIVERED PT ALIVE TO HOSPITAL, HOWEVER HE LATER DIED (NOT DUE TO THE PADS). THE CHIEF WAS ASKED IF THE PADS COULD HAVE BEEN DISLODGED AND ADHESION COMPROMISED DURING THE MOVE FROM THE HOUSE TO THE AMBULANCE AND ALTHOUGH THE CHIEF OF EMS WAS NOT PRESENT, HE STATED THAT THE PARAMEDICS ON SCENE ASSURED HIM THAT THE PADS WERE PLACED CORRECTLY. THE PATIENT DID RECEIVE BURNS/INJURY FROM EVENT, BUT DIED OF OTHER CAUSES.

  Patient problems: Cardiac Arrest; Superficial (First Degree) Burn

  MAUDE report 11904431 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080421. One submission often covers many models, so check the product and lot details in each record.

• Z-0587-2015 · Nov 11, 2014 · Terminated
  ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Con
• Z-0584-2015 · Nov 11, 2014 · Terminated
  ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Co
• Z-0585-2015 · Nov 11, 2014 · Terminated
  ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connecto
• Z-0583-2015 · Nov 11, 2014 · Terminated
  ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector"
• Z-0586-2015 · Nov 11, 2014 · Terminated
  ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector",
• Z-1434-2013 · Apr 26, 2013 · Terminated
  Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connect
• Z-1435-2013 · Apr 26, 2013 · Terminated
  Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a d
• Z-1372-2011 · Dec 17, 2010 · Terminated
  Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, def
• Z-1371-2011 · Dec 17, 2010 · Terminated
  Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, MI. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external
• Z-1951-2011 · Dec 5, 2008 · Terminated
  Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disp
• Z-1950-2011 · Dec 5, 2008 · Terminated
  Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, di