Curaplex 16242Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815277023795), received between Jan 9, 2026 and Jan 9, 2026 — 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Insufficient Device Problem Information

  COMPLAINT THAT GEL OF PAD IS REMAINING ATTACHED TO THE PACKAGING DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023175 ↗

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-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-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-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-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-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