Curaplex 16250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815277023832), received between Jun 24, 2021 and Jun 24, 2021 — classified as 1 malfunction.

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.

• MalfunctionJun 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT END USER EMS STATED THAT WHILE ATTEMPTING TO USE 16250 CURAPLEX MULTIFUNCTION DEFIB PAD, PHILIPS, ADULT NISSHA VERMED - 6600204H, LOT Y120720-01, THAT THE "PAD WILL CONNECT, BUT DEVICE WILL TELL THEM THAT THE PAD IS NOT CONNECTED". THERE WAS NO PATIENT INJURY OR DEATH INVOLVED WITH THE EVENT. THE END USER SAYS THE PRODUCT IS AVAILABLE FOR RETURN AND EVELAUTION, BUT AS OF 6/24/2021, IT HAS NOT BEEN RECEIVED. THE CUSTOMER REPORTED THEY USED WITH PHILIPS AED. NO ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063180 ↗

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-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