PadPro 2001M-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10653405042587), received between Jul 2, 2018 and Sep 15, 2025 — classified as 1 death, 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Sparking” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K014209, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathSep 15, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001M-C, ADULT/CHILD: 10KG. RADIOTRANELECTRODE, PHYSIOCONTROLQUIKCOMBO, WAS BEING USED DURING A RESUSCITATION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DEFIBRILLATOR PADS BURNED/SMOKING. SCALDED PATIENT AND FAILED TO DEFIBRILLATE. REPLACED PADS AND FUNCTIONED CORRECTLY. 2 LOTS USED, UNSURE AS TO WHICH LOT HAD ISSUE. PATIENT STATUS DECEASED.¿. FURTHER ASSESSMENT FOUND THAT THIS WAS A RESUSCITATION EVENT. THE BURN WAS DISCOVERED IMMEDIATELY AFTER PULLING BACK THE GOWN DURING THE EVENT. THE BURN WAS NOT EVALUATED AS THE PATIENT WAS DECEASED. THE BURN OCCURRED ON THE CHEST/UPPER ABDOMEN. THE REPORTER HAS STATED THAT AFTER DEFIBRILLATION "WE HAD RETURN OF SPONTANEOUS CIRCULATION BRIEFLY." AS FOR A CONNECTION BETWEEN DEVICE AND PATIENT DEATH, REPORTER STATED THEY ARE "UNSURE" AND ADDED, "WE WERE UNABLE TO RESUSCITATE THIS PATIENT IN A TIMELY MANNER. THE PATIENT WAS IN A SHOCKABLE ARRHYTHMIA, HENCE WHY DEFIBRILLATION WAS USED. IF WE WOULD HAVE BEEN ABLE TO SHOCK THE PATIENT OUT OF THE RHYTHM SOONER, IT MAY HAVE CHANGED THE OUTCOME OF THE RESUSCITATION EVENT, BUT THAT IS SPECULATIVE, AND I CANNOT SPECIFICALLY SAY THAT THIS WOULD HAVE CHANGED THE

  Patient problems: Arrhythmia; Burn(s)

  MAUDE report 23053740 ↗
• InjuryJun 14, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M-C, PADPRO: AD; RTRANS EL/LW, 12X7, WAS USED IN AN UNKNOWN TYPE OF PROCEDURE ON (B)(6) 2022 AND DURING POST-OP IT WAS REPORTED ¿STAFF FROM CAMPUS CALLED REPORTING THAT THEY HAVE EXPERIENCED A PATIENT INJURY DUE TO REMOVAL OF DEFIBRILLATION PAD 2001M-C. PATIENT'S SKIN WAS REMOVED.¿ THE DISCOVERY WAS MADE POST-OP. THE PAD WAS PLACED ON THE POSTERIOR BACK AND NO PREP OF THE AREA WAS CONDUCTED ON THE PATIENT PRIOR TO APPLICATION. THE DEVICE WAS REMOVED WITH A TWO-HAND SPLINTING TECHNIQUE. A SKIN TEAR WAS VISIBLE AND APPARENT AFTER REMOVAL OF PAD. PRE AND POST SKIN ASSESSMENTS WERE DONE. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. CURRENT STATUS OF THE PATIENT IS "DISCHARGED." THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE REPORT OF SKIN TEAR WITH REMOVAL OF THE PAD.

  Patient problems: Skin Tears

  MAUDE report 14684466 ↗
• MalfunctionMar 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001M-C, PADPRO:AD;RTRANS EL/LW, 12X7, WAS BEING USED DURING A CARDIOVERSION ON (B)(6) 2022 WHEN IT WAS REPORTED ¿PATIENT EXPERIENCING REDNESS IN SHAPE AND LOCATION OF THE DEFIB PADS AFTER BEDSIDE CARDIOVERSION. PATIENT STATES THE REDNESS FELT LIKE A SUNBURN.¿. THE REPORTER ADVISED THAT THERE WAS NO FORMAL DIAGNOSIS OF THE ¿BURN¿ AND THERE WAS NO REPORT OF MALFUNCTION OF THE DEVICE. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PATIENT WAS DISCHARGED AND ADVISED TO CONTACT THE NURSE MANAGER IF THE CONDITION WORSENED OR DID NOT SUBSIDE IN 1-2 DAYS. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Insufficient Information

  MAUDE report 13789000 ↗
• MalfunctionOct 14, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 2001M-C, PAD PRO DEFIB PADS WERE USED IN THE CATHERIZATION LAB DURING A PROCEDURE ON (B)(6) 2019. THEY HAD TO USE MULTIPLE PADS FROM A COUPLE OF DIFFERENT LOTS AND EXPERIENCED NO EKG READINGS. THE PADS WERE REPLACED WITH COMPETITOR PADS AND TRACING WAS PERFORMED AS NORMAL. THE CONMEDS REPRESENTATIVE WAS NOTIFIED AT THE END OF THE DAY AND IMMEDIATELY RESPONDED WITH NO RETURN COMMUNICATION. HE STOPPED ONSITE THE NEXT MORNING TO GATHER SAMPLES, AND INTEL OF SITUATION AND WHAT IS GOING TO HAPPEN. THE CURRENT STATUS OF THE PATIENT IS STABLE. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9187311 ↗
• MalfunctionOct 14, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 2001M-C, PAD PRO DEFIB PADS WERE USED IN THE CATHERIZATION LAB DURING A PROCEDURE ON (B)(6) 2019. THEY HAD TO USE MULTIPLE PADS FROM A COUPLE OF DIFFERENT LOTS AND EXPERIENCED NO EKG READINGS. THE PADS WERE REPLACED WITH COMPETITOR PADS AND TRACING WAS PERFORMED AS NORMAL. THE CONMEDS REPRESENTATIVE WAS NOTIFIED AT THE END OF THE DAY AND IMMEDIATELY RESPONDED WITH NO RETURN COMMUNICATION. HE STOPPED ONSITE THE NEXT MORNING TO GATHER SAMPLES, AND INTEL OF SITUATION AND WHAT IS GOING TO HAPPEN. THE CURRENT STATUS OF THE PATIENT IS STABLE. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9187270 ↗
• MalfunctionSep 30, 2019Therapeutic or Diagnostic Output Failure; No Pacing; No Visual Prompts/Feedback; Therapeutic or Diagnostic Output Failure; No Pacing; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED THE 2001M-C, PAD PRO WAS DEFECTIVE AND NOT WORKING DURING USE. FURTHER CLARIFICATION WAS RECEIVED. IT WAS STATED THAT DURING A CODE, THE STAFF HOOKED UP THE PADS AND MACHINE. THEY GOT NO READING. THEY TRIED ANOTHER MACHINE, STILL HAD NO READINGS. THEY CHANGED THE PADS USING ANOTHER OF THE SAME PAD BUT DIFFERENT LOT NUMBER AND IT WORKED. THERE WAS NO PATIENT INJURY OR IMPACT REPORTED. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9136513 ↗
• InjurySep 5, 2018Failure to Conduct; Blocked Connection; Failure to Conduct; Blocked Connection

  THE CUSTOMER REPORTED AN ISSUE OCCURRING WITH 2001M-C, PADPRO, P/C DC, TRANSPARENT-L/WS DURING A REDO MITRAL VALVE REPLACEMENT ON (B)(6) 2018. THE PROCEDURE INVOLVED A (B)(6) MALE WITH SEVERE MITRAL VALVE STENOSIS WHO WAS STATUS POST AORTIC VALVE REPLACEMENT IN 2005. IN PREPARATION FOR THE START OF THE PROCEDURE, THE ABOVE NOTED DEFIBRILLATION ELECTRODES WERE PLACED ON THE PATIENT. NURSING STAFF RESPONSIBLE FOR THE PLACEMENT OF THESE PADS INDICATED THAT THERE WAS INITIALLY GOOD ADHERENCE OF THE PAD TO THE PATIENT'S SKIN. DURING REWARMING, THE PATIENT WAS NOTED TO GO INTO VENTRICULAR FIBRILLATION. TWO ATTEMPTS WERE MADE TO DEFIBRILLATE THE PATIENT. HOWEVER, THERE WAS NO CARDIOVERSION NOTED. AN ERROR MESSAGE OF "NO CONNECTION" (OR SIMILAR) WAS NOTED ON THE MONITOR. THE INITIAL SET OF PADS WERE EXCHANGED FOR A SECOND SET OF THE SAME BRAND AND SAME LOT NUMBER. THE CABLE BETWEEN THE DEFIBRILLATOR AND THE PADS WAS EXCHANGED BUT THE ERROR MESSAGE PERSISTED. A SECOND DEFIBRILLATOR WAS BROUGHT INTO THE ROOM AND CONNECTED TO THE CABLES, HOWEVER THE ERROR MESSAGE PERSISTED AND THE STAFF ARE UNABLE TO CARDIOVERT THE PATIENT. ANOTHER STAFF MEMBER WAS ABLE TO LOCATE A THIRD SET OF DEFIBRILLATOR

  Patient problems: Ventricular Fibrillation

  MAUDE report 7847971 ↗
• MalfunctionJul 2, 2018Sparking; Sparking

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A CARDIOVERSION WITH 2001M-C PAD, A SPARK WAS WITNESSED WHERE THE WIRE ENTERED THE PAD. THE PAD INVOLVED WAS THE ANTERIOR PAD PLACED ON THE PATIENT'S MIDSTERNUM. THE CARDIOVERSION WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL INTERVENTIONS REQUIRED. NO PATIENT INJURY OR SURGICAL DELAYS WAS REPORTED. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Code Available

  MAUDE report 7655064 ↗
• MalfunctionJul 2, 2018Sparking; Sparking

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A CARDIOVERSION WITH 2001M-C PAD, A SPARK WAS WITNESSED WHERE THE WIRE ENTERED THE PAD. THE PAD INVOLVED WAS THE ANTERIOR PAD PLACED ON THE PATIENT'S MIDSTERNUM. UPON REMOVING THE PAD, A SMALL PINK SPOT WAS OBSERVED. THE CARDIOVERSION WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL INTERVENTIONS REQUIRED. NO PATIENT INJURY OR SURGICAL DELAYS WAS REPORTED. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Code Available

  MAUDE report 7654867 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014209, P200004. One submission often covers many models, so check the product and lot details in each record.

• Z-0454-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillat
• Z-0456-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
• Z-0455-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
• Z-1317-2013 · May 3, 2013 · Terminated
  PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtro