PadPro 2001Recalls & reported problems

Conmed Corporation · PADPRO Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, Adult/Child greater than 10 kg Radiotransparent Electrode, Anderson/Universal 60" (152 cm) · Class 3

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405004714), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Emits Odor” (1 report).

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

Device problems

Device Emits Odor1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 10, 2021Device Emits Odor
PATIENT UNDERWENT CARDIOVERSION PROCEDURE. AFTER DEFIBRILLATOR WAS USED, THERE WAS A STRONG ODOR OF SOMETHING BURNING. DEFIBRILLATOR AND PADS WERE IMMEDIATELY REMOVED FROM PATIENT. UNSURE IF ODOR WAS FROM DEFIBRILLATOR OR PADS USED ON BACK. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Insufficient Information
MAUDE report 11462439 ↗

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-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	`10653405004714`
Brand	PadPro
Model	2001
Company	Conmed Corporation
Product code	MKJ · Automated External Defibrillators (Non-Wearable)
Class	Class 3
FDA submission	K014209, P200004
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	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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