PadPro 2001H-CRecalls & reported problems

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405064299), received between Nov 27, 2017 and Jan 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Sparking” (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

Device problems

Sparking2
Flare or Flash1

Patient problems

Burn(s)1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 10, 2018Sparking; Sparking
A MEDWATCH SUBMITTED BY THE USER FACILITY REPORTED THAT DURING A CARDIOVERSION, THERE WAS A SPARK/FLASH FROM THE 2001H-C PAD. CARDIOVERSION WAS UNSUCCESSFUL. UPON GATHERING ADDITIONAL INFORMATION THE FACILITY STATED THE PATIENT SUSTAINED A BURN/REDNESS AROUND AN UNSPECIFIED AREA. THE AREA WAS TREATED WITH ALOE VERA. TO DATE, ADDITIONAL INFORMATION REGARDING CURRENT PATIENT STATUS, DEGREE OF THE BURNS AND PROCEDURE HAS NOT BEEN MADE AVAILABLE. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.
Patient problems: Burn(s)
MAUDE report 7179516 ↗
Nov 27, 2017Sparking; Flare or Flash
A SPARK/ FLASH FROM A DEFIB PAD OCCURRED DURING A CARDIOVERSION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7059113 ↗

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-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-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-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

Device details

UDI-DI	`10653405064299`
Brand	PadPro
Model	2001H-C
Company	Conmed Corporation
Product code	MKJ · Automated External Defibrillators (Non-Wearable)
Class	Class 3
FDA submission	K014209
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Aug 18, 2025

Device type (GMDN): Multifunction cardiac treatment electrode

An electrical conductor designed to be applied to an adult and/or paediatric patient for automatic or manual defibrillation, external pacing, and cardioversion through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses (e.g., defibrillator); it commonly will also be used for electrocardiographic monitoring. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.

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All Automated External Defibrillators (Non-Wearable) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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