PadPro 2001MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10653405042570), received between Apr 26, 2024 and Jun 29, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M ADULT/CHILD=10KG RADIOTRANS ELECTRD,PHYSIOCONTROLQUIKCOMBODEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A HEMODYNAMICS PROCEDURE WHEN IT WAS REPORTED ¿BURN OCCURS IMMEDIATELY AFTER THE FIRST SHOCK.¿. FURTHER ASSESSMENT FOUND THAT THE PATIENT EXPERIENCED A 1ST DEGREE BURN AND IT WAS TREATED WITH TROLAMINE LOCATED ON THE ANTERIOR CHEST. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF SURGICAL INTERVENTION 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: Superficial (First Degree) Burn

  MAUDE report 25649934 ↗
• InjuryJun 29, 2026Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M ADULT/CHILD=10KG RADIOTRANS ELECTRD,PHYSIOCONTROLQUIKCOMBODEVICE WAS BEING USED ON (B)(6) 2026 DURING A HEMODYNAMICS PROCEDURE WHEN IT WAS REPORTED "ANOTHER INCIDENT HAPPENED WITH THE SAME BATCH OF PADPRO UNITS, A BURN OCCURS IMMEDIATELY AFTER THE FIRST SHOCK AT 200 J. ADDITIONALLY, A DIFFERENT DEFIBRILLATOR WAS USED AND THE ISSUE STILL OCCURRED." FURTHER ASSESSMENT FOUND THAT THE PATIENT EXPERIENCED A 2ND DEGREE BURN AND IT WAS TREATED WITH GRADE 2 DRESSING WITH GREASY GAUZE LOCATED ON THE ANTERIOR CHEST. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT EXPERIENCING A 2ND DEGREE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25649880 ↗
• MalfunctionMar 31, 2026Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 2001M ADULT/CHILD=10KG RADIOTRANS ELECTRD,PHYSIOCONTROLQUIKCOMBO DEVICE WAS BEING USED DURING A HEMODYNAMICS PROCEDURE ON (B)(6) 26 WHEN IT WAS REPORTED ¿THE APPLICATION OF SHOCK IN SYNCHRONIZED CARDIOVERSIONS, WITH MAXIMUM ENERGY OF 360 J, IN AF, LEAVES BURNS ON THE PATIENT¿S CHEST (THE OUTER EDGE). IT IS NECESSARY TO CONFIRM THE CHARACTERISTICS AND GEL OF THE ELECTRODES.¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS COMPLETED WITH NO INFORMATION FOUND. 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 PATIENT OBTAINING AN UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 24740549 ↗
• MalfunctionJan 7, 2026Defibrillation/Stimulation Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 2001M, ADULT/CHILD=10KG RADIOTRANS ELECTRD, PHYSIOCONTROLQUIKCOMB, WAS BEING USED DURING A DEFIB PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE CATH LAB HAS EXPRESSED CONCERNS ABOUT THE FORMULARY CHANGE TO THE DEFIB PADS. WHERE (NAME) WAS IN THE ROOM AND THE PATIENT WENT INTO VTACH, AND SHE WALKED OVER TO SHOCK THE PATIENT, AND THE DEFIB PAD WASN¿T CAPTURING. SHE THEN LOOKED AT THE PATIENT¿S CHEST AND THE DEFIB PADS WERE CURLING AND NOT ADHERING TO THE SKIN. THE SITUATION WAS RESOLVED WHEN (DOCTOR) PULLED THE WIRE FOR THE DEFIB PAD, BUT HAD HE NOT DONE THAT, THE STAFF WOULD¿VE HAD TO HOLD THE PADS DOWN TO THE SKIN WHILE SHOCKING THE PATIENT POTENTIALLY CAUSING INJURY TO THE STAFF AND DELAYED CARE TO THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FROM THE REPORTER FOUND, ¿THE ISSUE FROM THIS PARTICULAR FACILITY IS ADHESION RELATED, PEELING UP ON THE EDGES WHICH CAUSES POOR PAD TO PATIENT CONTACT. THIS SYSTEM DOES PLACE THE PADS UNDERNEATH A BAIR HUGGER PRIOR TO PLACING THEM ON PATIENTS TO WARM THEM UP. LEADERSHIP FROM (FACILITY)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988337 ↗
• MalfunctionJan 7, 2026Defibrillation/Stimulation Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 2001M, ADULT/CHILD=10KG RADIOTRANS ELECTRD, PHYSIOCONTROLQUIKCOMB, WAS BEING USED DURING A DEFIB PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE CATH LAB HAS EXPRESSED CONCERNS ABOUT THE FORMULARY CHANGE TO THE DEFIB PADS. WHERE (NAME) WAS IN THE ROOM AND THE PATIENT WENT INTO VTACH, AND SHE WALKED OVER TO SHOCK THE PATIENT, AND THE DEFIB PAD WASN¿T CAPTURING. SHE THEN LOOKED AT THE PATIENT¿S CHEST AND THE DEFIB PADS WERE CURLING AND NOT ADHERING TO THE SKIN. THE SITUATION WAS RESOLVED WHEN (DOCTOR) PULLED THE WIRE FOR THE DEFIB PAD, BUT HAD HE NOT DONE THAT, THE STAFF WOULD¿VE HAD TO HOLD THE PADS DOWN TO THE SKIN WHILE SHOCKING THE PATIENT POTENTIALLY CAUSING INJURY TO THE STAFF AND DELAYED CARE TO THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FROM THE REPORTER FOUND, ¿THE ISSUE FROM THIS PARTICULAR FACILITY IS ADHESION RELATED, PEELING UP ON THE EDGES WHICH CAUSES POOR PAD TO PATIENT CONTACT. THIS SYSTEM DOES PLACE THE PADS UNDERNEATH A BAIR HUGGER PRIOR TO PLACING THEM ON PATIENTS TO WARM THEM UP. LEADERSHIP FROM (FACILITY)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988336 ↗
• MalfunctionDec 17, 2025Failure to Conduct; Failure to Conduct

  THE CUSTOMER REPORTED THAT THE THAT THE 2001M ADULT/CHILD=10KG RADIOTRANS ELECTRODE,PHYSIO CONTROL QUIK COMBO DEVICE WAS BEING USED DURING A VENTRICULAR FIBRILLATION ABLATION ON (B)(6) 2025 WHEN IT WAS REPORTED ¿ENERGY IS COMING THROUGH BUT NOT CONVERTING THE PATIENTS. THE FIRST INCIDENT WAS ON (B)(6) 25 DURING A VENTRICULAR FIBRILLATION ABLATION; ONCE THE HANDS-OFF PADS DID NOT WORK THE RN USED THE MANUAL PADDLES TO DEFIBRILLATE THE PATIENT OUT OF VT. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION 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 23826991 ↗
• MalfunctionApr 26, 2024Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER REPORTED THAT THE 2001M, PADPRO:AD;RTRANS EL, 12X7 WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY 03APR24 WHEN IT WAS REPORTED ¿DURING CODE BLUE LIFE PACK DISPLAYED "CONNECT ELECTRODES" MULTIPLE TIMES LIFEPACK SWAPPED PADS SWAPPED.¿. FURTHER ASSESSMENT QUESTIONS 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 INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191088 ↗

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