PadPro 2001Z-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10653405042488), received between Feb 18, 2020 and Dec 22, 2025 — classified as 1 death, 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Noise, Audible

  AFTER ANESTHESIA PROVIDED SEDATION; 200 J OF SYNCHRONIZED ENERGY USED, AND A SMALL POP OCCURRED AT THE SITE OF THE PAD. SO, WE CHANGED THE PADS AND REPEATED THE CARDIOVERSION WITH 200 J AND PRESSURE, AND PATIENT CONVERTED TO SINUS RHYTHM. THE PADS WERE REMOVED THERE DOES NOT APPEAR TO BE ANY BURN MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862775 ↗
• MalfunctionSep 29, 2025Failure to Read Input Signal; Failure to Read Input Signal

  A CUSTOMER REPORTED THAT THE 2001Z-C, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE, ZOLL DEVICE WAS USED IN A CARDIOVERSION PROCEDURE ON (B)(6) 2025, AND ¿IN THE EMERGENCY ROOM THE PATIENT RECEIVED A CARDIOVERSION. NEEDED TO SWITCH OUT PADS TO COMPLETE PROCEDURE. PAT REMAINED 5 ADDITIONAL DAYS IN HOSPITAL. DELAYED PUSHING MEDS, PATIENT CARE, AND CARDIOVERSION. NO DIRECT INJURY OR ADVERSE EFFECT OF PADS. PT STAYED AS AN INPATIENT FOR 6 DAYS AFTER RECEIVEING THE CARDIOVERSION, THEN LEFT HEART CATH, THEN PPM IMPLANTATION¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH A DELAY OF 3 TO 5 MINUTES. FURTHER ASSESSMENT FOUND THE "PADS WERE NOT READING A RHYTHM" AND "WHEN THE PADS WERE NOT READING THE RHYTHM, THEY WERE NOT USED FOR SHOCKING THE PATIENT- THEY WERE REMOVED AND A NEW SET WAS USED.". THIS WAS THE FIRST APPLICATION OF THE PADS AND THEY WERE FULLY ADHERENT TO THE PATIENT'S SKIN. THE PATIENT¿S STATUS IS REPORTED AS ¿DISCHARGED FROM INPATIENT STATUS.¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23165345 ↗
• MalfunctionAug 27, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001Z-C, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE, ZOLL, WAS BEING USED DURING A TRANSCUTANEOUS PACING PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿ZOLL DEFIBRILLATOR FAILED TO TRANSCUTANEOUSLY PACE IN 3 INSTANCES, (LOCATION). ONLY CONNECTION DISCOVERED SO FAR IS SAME LOT NUMBER FOR DEFIB PADS¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION OF THE PATIENT. WHEN ASKED THE REPORTER GAVE FURTHER INFORMATION STATING, "I WOULD SAY IT WAS A NORMAL CASE THAT TURNED INTO AN EMERGENCY. WE HAVE THEM ON ¿JUST IN CASE¿ AND THEN, WHEN WE NEED THEM, THEY ARE THERE. SO, IN OUR CASE, WE DID A NORMAL OUTPATIENT AND WHEN WE NEEDED THEM AS A BACK UP, THAT IS WHEN IT FAILED." 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 22902179 ↗
• MalfunctionAug 27, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001Z-C, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE, ZOLL, WAS BEING USED DURING A TRANSCUTANEOUS PACING PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿ZOLL DEFIBRILLATOR FAILED TO TRANSCUTANEOUSLY PACE IN 3 INSTANCES, (LOCATION). ONLY CONNECTION DISCOVERED SO FAR IS SAME LOT NUMBER FOR DEFIB PADS¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION OF THE PATIENT. WHEN ASKED THE REPORTER GAVE FURTHER INFORMATION STATING, "I WOULD SAY IT WAS A NORMAL CASE THAT TURNED INTO AN EMERGENCY. WE HAVE THEM ON ¿JUST IN CASE¿ AND THEN, WHEN WE NEED THEM, THEY ARE THERE. SO, IN OUR CASE, WE DID A NORMAL OUTPATIENT AND WHEN WE NEEDED THEM AS A BACK UP, THAT IS WHEN IT FAILED." 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 22902177 ↗
• MalfunctionAug 27, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE DEVICE, 2001Z-C, ADULT/CHILD = 10 KG RADIOTRANSPARENT ELECTRODE, ZOLL, WAS BEING USED DURING A TRANSCUTANEOUS PACING PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿ZOLL DEFIBRILLATOR FAILED TO TRANSCUTANEOUSLY PACE IN 3 INSTANCES, (LOCATION). ONLY CONNECTION DISCOVERED SO FAR IS SAME LOT NUMBER FOR DEFIB PADS¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION OF THE PATIENT. WHEN ASKED THE REPORTER GAVE FURTHER INFORMATION STATING, "I WOULD SAY IT WAS A NORMAL CASE THAT TURNED INTO AN EMERGENCY. WE HAVE THEM ON ¿JUST IN CASE¿ AND THEN, WHEN WE NEED THEM, THEY ARE THERE. SO, IN OUR CASE, WE DID A NORMAL OUTPATIENT AND WHEN WE NEEDED THEM AS A BACK UP, THAT IS WHEN IT FAILED." 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 22902176 ↗
• InjuryMay 15, 2024Noise, Audible; Noise, Audible

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001Z-C, PADPRO:ZOLL DC;TRANSPARENT-L/WS, 12X7, 10/CS WAS BEING USED ON APPROXIMATELY (B)(6) 2024 AND A ¿70/M IN THE ED UNDERGOING CARDIOVERSION FOR AFIB. HIS CHEST WAS SHAVED AND NO GEL OR MOISTURE WAS PRESENT. WHEN THE PATIENT WAS SHOCKED AT 200 J, A POP WAS HEARD AND THE SMELL OF SINGED SKIN WAS DETECTABLE IN THE AIR. THE PATIENT HAD SOME SMALL AREAS OF SKIN THAT WERE REDDENED AND CAME OFF WITH THE PADS WHEN THEY WERE REMOVED.¿ THE PROCEDURE WAS COMPLETED AND THERE WAS A ¿MILD BURN ALONG EDGE OF PAD¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF SKIN REMOVED AND BURN OF UNKNOWN DEGREE.

  Patient problems: Burn(s); Skin Tears

  MAUDE report 19323322 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DISTRIBUTOR REPORTED ON BEHALF ON THEIR CUSTOMER THAT THE 2001Z-C, PADPRO:ZOLL DC;TRANSPARENT-L/WS, 12X7, 10/CS DEVICE WAS BEING USED DURING AN OUTPATIENT CARDIOVERSION PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿A PATIENT WAS BURNED BY MATERIAL.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PATIENT WAS DIAGNOSED WITH AN UNKNOWN DEGREE OF BURN AND WAS TREATED WITH SILVADINE CREAM. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN AMOUNT OF DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿NO ADDITIONAL FOLLOW UP¿. THERE WAS NO REPORT EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO PATIENT BEING DIAGNOSED WITH UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 17964170 ↗
• InjuryOct 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 2001Z-C, PADPRO:ZOLL DC;TRANSPARENT-L/WS, 12X7, 10/CS WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿BURNED PATIENT. UNKNOWN AREA. NO PERMANENT DAMAGE¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO PATIENT OBTAINING AN UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 17959471 ↗
• DeathMar 27, 2023Sparking; Sparking

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (B)(4) ON 27FEB23. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST 2001Z-C, PADPRO:ZOLL DC;TRANSPARENT-L/WS, 12X7, 10/CS, THAT WAS BEING USED DURING A CODE PROCEDURE IN THE CRITICAL CARE UNIT THAT OCCURRED ON (B)(6) 2022. THE REPORT STATED ¿ELDERLY PATIENT HAD A SUDDEN DECREASE IN OXYGEN LEVELS AND LEVEL OF CONSCIOUSNESS. A CODE WAS CALLED AND ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS STARTED. DURING THE FIRST DEFIBRILLATION ATTEMPT, SPARKS AND A SMOKE SMELL WERE NOTED. THERE WAS NO APPARENT HARM TO THE PATIENT FROM THE SPARK EVENT. THE DEFIBRILLATOR PADS WERE ADJUSTED FOR BETTER SKIN ADHERENCE AND A SUBSEQUENT DEFIBRILLATION ATTEMPT WAS PERFORMED SUCCESSFULLY WITHOUT PROBLEMS. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED WITH A WEAK, THREADY PULSE AND HYPOTENSION. THE BEST EXPLANATION IS THE PADS WERE NOT FULLY ADHERED TO THE PATIENT¿S SKIN, LIKELY DUE TO THE HURRIEDNESS OF THE SITUATION, CONTRIBUTING TO THE SPARK AND SMOKE. THE PADS WERE ADJUSTED FOR BETTER ADHERENCE AND A SUBSEQUENT DEFIBRILLATION ATTEMPT DID NOT HAVE PROBLE

  Patient problems: Cardiac Arrest

  MAUDE report 16620392 ↗
• MalfunctionFeb 18, 2020Unable to Obtain Readings; Incomplete or Inadequate Connection; Unable to Obtain Readings; Incomplete or Inadequate Connection

  DURING A CABG PROCEDURE THE PADS WERE PLACED ON PATIENT AND THE ZOLL MONITOR READ "BAD CONNECTION". THEY BROUGHT IN A NEW MONITOR FROM A DIFFERENT ROOM AND PLACED SAME PADS ON SAME PATIENT AND THE MONITOR GAVE THE SAME MESSAGE, "BAD CONNECTION." BIOMED CHECKED THE MONITOR AND EVERYTHING CHECKED OUT TO BE WORKING PROPERLY. THEY ALSO HOOKED UP A NEW SET OF PADS AND RAN IT AT 30, 50, AND 100 JOULES AND IT NEVER READ "BAD CONNECTION. 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 9719878 ↗
• MalfunctionFeb 18, 2020Unable to Obtain Readings; Incomplete or Inadequate Connection; Unable to Obtain Readings; Incomplete or Inadequate Connection

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 2001Z-C, PAD PRO DEFFIB PADS, WERE USED DURING A CABG PROCEDURE THE FIRST PROCEDURE THE SAME MESSAGE CAME UP, "POOR CONTACT", "CHECK PADS". THE ZOLL MONITOR HAD NOT BEEN TESTED THAT MORNING. WE TURNED THE MONITOR OFF AND TURNED BACK ON TO THE DEFIBRILLATOR SETTING AND NEVER HAD AN ISSUE AFTER THAT. 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 9719877 ↗
• MalfunctionFeb 18, 2020Unable to Obtain Readings; Incomplete or Inadequate Connection; Unable to Obtain Readings; Incomplete or Inadequate Connection

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 2001Z-C, PAD PRO DEFFIB PADS, WERE USED DURING A CABG PROCEDURE THE PADS WERE PLACED ON PATIENT AND THE ZOLL MONITOR READ "BAD CONNECTION". THEY BROUGHT IN A NEW MONITOR FROM A DIFFERENT ROOM AND PLACED SAME PADS ON SAME PATIENT AND THE MONITOR GAVE THE SAME MESSAGE, "BAD CONNECTION." BIOMED CHECKED THE MONITOR AND EVERYTHING CHECKED OUT TO BE WORKING PROPERLY. THEY ALSO HOOKED UP A NEW SET OF PADS AND RAN IT AT 30, 50, AND 100 JOULES AND IT NEVER READ "BAD CONNECTION. 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 9719875 ↗

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-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-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-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