PadPro 2001HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405064282), received between May 17, 2018 and May 31, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K014209); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A CARDIOVERSION, THE 2001H PADS WERE NOT SHOCKING. THE PROCEDURE WAS COMPLETED WITH A 10 MINUTE DELAY AND WITH AN ALTERNATE DEVICE. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7559228 ↗
• MalfunctionMay 17, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A CARDIOVERSION THE 2001H "FAILED TO WORK, ERROR CODES WERE, FAILED TO SHOCK." THE PROCEDURE WAS COMPLETED WITH ALTERNATE PADS, WITH A DELAY FOR SWITCHING THE PADS. NO PATIENT INJURY REPORTED. THIS REPORT IS BEING RAISED ON THE BASIS OF A MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7523178 ↗

Recalls under the same FDA submission

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

• 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-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-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