Curaplex 16384Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815277023931), received between Apr 9, 2021 and Jan 7, 2026 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Insufficient Device Problem Information

  COMPLAINT THAT ADHESIVE IS COMING OFF OF PAD WHEN REMOVED FROM THE PAPER RELEASE LINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995573 ↗
• MalfunctionApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER ( EMS) REPORTED THAT A PATIENT PRESENTED ALREADY IN CARDIAC ARREST. "CURAPLEX PADS WERE PLACED ON PATIENT, SHOCK DELIVERED AND MONITOR CONFIRMED BUT THE ECG CONFIRMED IT DIDN'T DELIVER THE SHOCK. " THE EMS REMOVED THE PADS, PLACED PHYSIO CONTROL PADS ( DIFFERENT PRODUCT) AND SHOCK DELIVERED PER MONITOR AND CONFIRMED WITH ECG. ALTHOUGH SECOND SHOCK WAS ABLE TO BE DELIVERED, THE PATIENT DID NOT SURVIVE THE EVENT. ORIGINALLY THE END USER WAS GOING TO RETURN THE PRODUCT FOR EVALUATION AND FURTHER INVESTIGATION, BUT THEN CONFIRMED THEY WERE NO LONGER AVAILABLE. FOLLOW UP INFORMATION FROM THE USER FOUND THAT THE USER WAS TRAINED ON HOW TO USE THE PRODUCT, THE PADS WERE USED WITH A PHYSIO CONTROL LIFEPAK 15 UNIT, THE PADS WAS BEING USED DURING AN EMERGENCY CARDIAC ARREST ON A FEMALE PATIENT, WITH ENERGY SETTING OF 200J. THE END USER STATED, NO SHOCK WAS DELIVERED BUT THERE WAS AN ECG SIGNAL PRESENT. PER THE USER THERE WAS NO AUDIBLE ALARM FROM THE UNTI AND THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 11641817 ↗
• MalfunctionApr 9, 2021Output Problem; Output Problem

  ON (B)(6) 2020, AND END USER REPORTED THAT THEY WERE USING THE DEFIB PADS DURING A RESUSCITATION ATTEMPT AND THE PADS WERE" NOT READING / WORKING ON LP15." THE CONNECTIONS WERE INSPECTED, UNPLUGGED, AND TRIED AGAIN WITH NO READING. ANOTHER SET OF DEFIB PADS WERE USED AND COULD NOT GET A READING FOR THOSE. VERY LIMITED INFORMATION WAS RECEIVED FROM THE CUSTOMER AND NO SAMPLES WERE RETURNED FOR INVESTIGATION, ALTHOUGH THERE WERE MULTIPLE ATTEMPTS. A SERIOUS DEATH OR INJURY WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11641815 ↗
• MalfunctionApr 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THERE WAS NO DEATH OR SERIOUS INJURY REPORTED AS A RESULT OF EVENT. A MALFUNCTION WAS REPORTED, ALTHOUGH UNCONFIRMED THROUGH INVESTIGATION. AS PER THE END USER, " THE PACER PADS FAILED TO WORK. PACER PADS WERE PLACED UPON THE PATIENT INITIALLY. THE STANDARD LIMB LEADS HAD TO BE PUT ON IMMEDIATELY FOLLOWING THE PACER PADS IN ORDER TO SHOW A RHYTHM. THE MONITOR SHOWED NOTHING WITH JUST THE PACER PADS." THE USER REPORTED THAT THE PADS WERE "PLUGGED IN" AND THEN THE PACER CORD ATTACHED TO THE MONITOR WAS DISCONNECTED AND THEN RECONNECTED, AND THEN THE MONITOR WAS TURNED OFF AND THEN BACK ON. THE USER STATED WHEN THEY REPLACED THE PADS THEY WORKED AND THIS CONFIRMED TO THEM THAT IS WAS AN ISSUE WITH THE PADS AND NOT THE MONITOR. THE END USER CONFIRMED THAT WHILE TROUBLE SHOOTING, THE MONITOR LEADS WERE PLACED ONTO THE PATIENT TO CONFIRM THE RHYTHM TO PREVENT INTERRUPTION OF PATIENT CARE.

  Patient problems: Insufficient Information

  MAUDE report 11641805 ↗

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-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-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-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-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-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-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-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
• 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