PadPro 2516M-PCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405042631), received between Jan 7, 2025 and Jan 28, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Conduct” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K020203, P200004); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Failure to Conduct

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 2516M-PC DEFIB ELECTRODE ADULT, RADIOTRANS PADS W/PRECONNECT, MEDTRONIC, DEVICE WAS BEING USED ON (B)(6) 2026 WHEN IT WAS REPORTED WAS REPORTED ¿A PATIENT WHO WENT INTO RESUSCITATION AND HAD TO BE GIVEN AN ELECTRIC SHOCK. THE PATIENT REQUIRED ELECTRICAL DEFIBRILLATION; THEREFORE, DEFIBRILLATOR PADS WERE APPLIED. PADPRO PADS WERE APPLIED TO THE PATIENT, AND A MEDTRONIC DEFIBRILLATOR WAS CONNECTED. THE PADPRO DID NOT TRANSMIT AND DID NOT FUNCTION. TWO ADDITIONAL DEFIBRILLATORS WERE USED, HOWEVER THE PADPRO STILL DID NOT FUNCTION. EVENTUALLY, THE DEFIBRILLATOR PADS WERE REPLACED WITH A NEW PADPRO SET. AFTER REPLACING THE PADS, DEFIBRILLATION WAS POSSIBLE AND THE PADS FUNCTIONED PROPERLY. NO HARM WAS CAUSED TO THE PATIENT.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202518 ↗
• InjuryJan 7, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE 2001M-C, ADULT/CHILD=10KG RADIOTRANELECTRODE, PHYSIOCONTROLQUIKCOMBO DEVICE WAS USED IN A PROCEDURE ON (B)(6)2024, AND "A PATIENT WAS CODING, AND THE ER NURSES WERE USING THE DEFIBRILLATOR ON THEM AND THE DEFIB PADS MALFUNCTIONED. THEY TRIED TO USE TWO MORE SETS OF PADS, AND THEY DID NOT WORK EITHER. THE PADS NOT ONLY DID NOT SHOCK THE PATIENT, BUT THEY DID NOT EVEN REGISTER. THANKFULLY THE AMBULANCE WAS STILL HERE, AND THEY WERE ABLE TO BORROW PADS FROM THEM (THAT WORKED) AND STABILIZED THE PATIENT.¿. PER FOLLOW-UP ASSESSMENT, THE PADS OBTAINED FROM EMS WERE "PLUGGED INTO OUR MONITOR AND WORKED PROPERLY.". THE PATIENT'S SKIN HAD BEEN PREPPED, THE SITE WAS CLEAN AND DRY, WITH NO BODY HAIR. THE DEVICE WAS INSPECTED BEFORE BEING INTRODUCED. THERE WERE NO FOLDS IN THE DEVICE, IT WAS FULLY ADHERED TO THE PATIENT SITE, WHICH WAS AT THE "RIGHT CHEST LEFT RIB". THE LOCATION OF THE PAD WAS CHANGED. THE IMPACT TO THE PATIENT WAS "PROLONGED DEFIBRILLATION, PT IN VFIB EXTENDED AMOUNT OF TIME". AS OF (B)(6) 2024, THE PATIENT'S STATUS IS "ALIVE AND REMAINS IN THE HOSPITAL". THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PATIENT

  Patient problems: Ventricular Fibrillation

  MAUDE report 21093780 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020203, P200004. One submission often covers many models, so check the product and lot details in each record.

• Z-0457-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
• Z-0458-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
• Z-0757-2007 · Mar 8, 2007 · Terminated
  PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA for: CONMED CORPORATION
• Z-0756-2007 · Mar 8, 2007 · Terminated
  PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for: CONMED CORPORATION Uti