PadPro 2516MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10653405042624), received between Jan 27, 2016 and Jan 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2516M, DEFIB ELECTRODE ADULT, RADIOTRANSLUCENT PADS, MEDTRONIC CONN, DEVICE LOT NUMBER Y11012403 WAS BEING USED DURING A NON-SURGICAL PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THE ISSUE IS THAT THE ADHESIVE HAS FAILED ON NEARLY ALL OF THESE REGARDLESS OF WHEN WE HAVE USED THEM. DURING A CARDIAC ARREST I HAVE SEVERAL REPORTS OF MY STAFF HAVING TO HOLD THE PADS ON THE PATIENT WITH THEIR OWN HANDS JUST TO DELIVER A SHOCK.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THEY ARE REPORTING THAT SINCE WE SWITCHED TO THE CONMED PRODUCT THE ITEMS HAVE NOT BEEN FUNCTIONING PROPERLY WHERE THE ADHESIVE DOES NOT STICK ON THE PATIENT AND THE MEDICS WERE BEING REQUIRED TO HOLD THE ELECTRODES IN PLACE BY HAND EVEN DURING A SHOCK. THIS WAS NOT REPORTED TO CONMED PREVIOUSLY, YOU CAN PROCEED WITH THIS BEING A SINGLE INCIDENT SINCE I HAVE NO SPECIFIC DATES OR PATIENT DETAILS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 21167227 ↗
• MalfunctionJan 16, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2516M, DEFIB ELECTRODE ADULT,RADIOTRANSLUCENT PADS,MEDTRONIC CONN, DEVICE LOT NUMBER Y09202409 WAS BEING USED DURING A NON-SURGICAL PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THE ISSUE IS THAT THE ADHESIVE HAS FAILED ON NEARLY ALL OF THESE REGARDLESS OF WHEN WE HAVE USED THEM. DURING A CARDIAC ARREST I HAVE SEVERAL REPORTS OF MY STAFF HAVING TO HOLD THE PADS ON THE PATIENT WITH THEIR OWN HANDS JUST TO DELIVER A SHOCK.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THEY ARE REPORTING THAT SINCE WE SWITCHED TO THE CONMED PRODUCT THE ITEMS HAVE NOT BEEN FUNCTIONING PROPERLY WHERE THE ADHESIVE DOES NOT STICK ON THE PATIENT AND THE MEDICS WERE BEING REQUIRED TO HOLD THE ELECTRODES IN PLACE BY HAND EVEN DURING A SHOCK. THIS WAS NOT REPORTED TO CONMED PREVIOUSLY, YOU CAN PROCEED WITH THIS BEING A SINGLE INCIDENT SINCE I HAVE NO SPECIFIC DATES OR PATIENT DETAILS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 21167226 ↗
• MalfunctionJan 16, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2516M, DEFIB ELECTRODE ADULT, RADIOTRANSLUCENT PADS, MEDTRONIC CONN, DEVICE LOT NUMBER Y08282401 WAS BEING USED DURING A NON-SURGICAL PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THE ISSUE IS THAT THE ADHESIVE HAS FAILED ON NEARLY ALL OF THESE REGARDLESS OF WHEN WE HAVE USED THEM. DURING A CARDIAC ARREST I HAVE SEVERAL REPORTS OF MY STAFF HAVING TO HOLD THE PADS ON THE PATIENT WITH THEIR OWN HANDS JUST TO DELIVER A SHOCK.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THEY ARE REPORTING THAT SINCE WE SWITCHED TO THE CONMED PRODUCT THE ITEMS HAVE NOT BEEN FUNCTIONING PROPERLY WHERE THE ADHESIVE DOES NOT STICK ON THE PATIENT AND THE MEDICS WERE BEING REQUIRED TO HOLD THE ELECTRODES IN PLACE BY HAND EVEN DURING A SHOCK. THIS WAS NOT REPORTED TO CONMED PREVIOUSLY, YOU CAN PROCEED WITH THIS BEING A SINGLE INCIDENT SINCE I HAVE NO SPECIFIC DATES OR PATIENT DETAILS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 21167225 ↗
• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 2516M, DEFIB ELECTRODE ADULT, RADIOTRANSLUCENT PADS, MEDTRONIC CONN, WAS BEING USED DURING AN UNKNOWN EMERGENCY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿LAST NIGHT, THE MUNSTER ICU STAFF ENCOUNTERED ISSUES WITH THE HANDS-OFF PADS. WHEN THE STAFF OPENED THE PACKAGE TO PLACE THEM ON THE PATIENT DURING AN EMERGENCY, THE GEL THAT IS ATTACHED TO THEM WAS STICKING TO THE PAPER THAT PEELS OFF INSTEAD OF STAYING ON THE PAD MAKING THEM UNUSABLE. STAFF OPENED MULTIPLE PACKS WITH THE SAME ISSUE. THIS IS A SAFETY CONCERN AS THESE PADS ARE USED AS A PACEMAKER AND TO DEFIBRILLATE DURING A CODE BLUE. THE PACKS WERE NOT EXPIRED. THE ONE THAT IS LEFT IN THE UNIT DOES NOT EXPIRE UNTIL 2027. I TRIED SOME THAT ARE A DIFFERENT LOT NUMBER AND HAD NO ISSUES. I PULLED THE ONES WITH THE SAME LOT NUMBER AS BELOW. IT APPEARS TO BE ISOLATED TO THAT PARTICULAR LOT NUMBER.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, TO DATE NO FURTHER INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065896 ↗
• MalfunctionFeb 1, 2016Pacing Problem; Communication or Transmission Problem

  AS REPORTED, DURING SURGICAL PLACEMENT OF A BIVENTRICULAR ICD (INTERNAL CARDIAC DEFIBRILLATOR), A PADPRO MULTIFUNCTION ELECTRODE WAS BEING UTILIZED IN CONJUNCTION WITH A LIFEPAK 20 MONITOR WITH PACING CAPABILITY. SIGNALS FAILED DURING A PERIOD OF ASYSTOLE RESULTING IN THE INABILITY TO CARDIAC PACE THE PATIENT. THE SURGICAL TEAM CONDUCTED DIRECT LEFT VENTRICLE PACING UNTIL THE CARDIAC TRACING RETURNED ON THE LIFEPAK 20. REPORTEDLY THE CARDIAC TRACING RETURNED LATER IN THE CASE AND THEN CEASED AGAIN. THERE WAS NO INJURY TO THE PATIENT AND IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME WITH NO COMPLICATIONS EXPERIENCED AFTER LEAVING THE CARDIAC LAB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5401241 ↗
• MalfunctionJan 27, 2016Defibrillation/Stimulation Problem; Device Operates Differently Than Expected

  ON (B)(6) 2015 PATIENT WENT INTO CARDIAC ARREST AT THE END-USER FACILITY. TWO (2) UNSUCCESSFUL ATTEMPTS TO DEFIBRILLATE THE PATIENT WERE DONE WITH A LIFEPAK-20 DEFIBRILLATOR AND A TWO (2) SEPARATE SETS OF PADPRO MFES, MULTI-FUNCTION ELECTRODES, CATALOG NUMBER 2516M, LOT Y03171509. BOTH OF THESE SET-UPS FAILED TO DEFIBRILLATE. A THIRD SET OF PAD PRO MFES WAS ATTACHED TO THE PATIENT, DIFFERENT LOT NUMBER, AND THE PATIENT WAS SUCCESSFULLY DEFIBRILLATED. THERE WAS A TWO MINUTE DELAY DUE TO THE NEED TO CHANGE THE MFES ON THE PATIENT. THE PATIENT WAS TRANSPORTED TO CRITICAL CARE UNIT IN STABLE CONDITION. CURRENT STATUS OF PATIENT IS REPORTED BY END-USER FACILITY AS "FINE".

  Patient problems: Complaint, Ill-Defined

  MAUDE report 5392686 ↗

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-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-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-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