PadPro 2001Z-PCRecalls & reported problems

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

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 10653405042495), received between Feb 21, 2025 and Feb 21, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Arcing” (2 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Arcing2

Patient problems

Superficial (First Degree) Burn2

Recent adverse event reports

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

MalfunctionFeb 21, 2025Arcing; Arcing
THE CUSTOMER REPORTED THAT THE 2001Z-PC, ADULT/CHILD =10 KG RADIOTRANSPARENT ELECTRODE, LOT NUMBER Y09032401 WAS BEING USED ON (B)(6) 2025 DURING A CARDOIVERSION PROCEDURE WHEN IT WAS REPORTED ¿AN ARC OCCURRED DURING CARDIOVERSION USING THE PADPRO 2001Z-PC...ONE HAD A SUPERFICIAL BURN.¿ 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: Superficial (First Degree) Burn
MAUDE report 21433156 ↗
MalfunctionFeb 21, 2025Arcing; Arcing
THE CUSTOMER REPORTED THAT THE 2001Z-PC, ADULT/CHILD =10 KG RADIOTRANSPARENT ELECTRODE, LOT NUMBER: Y11182402 WAS BEING USED ON 08JAN2025 DURING A CARDOIVERSION PROCEDURE WHEN IT WAS REPORTED ¿AN ARC OCCURRED DURING CARDIOVERSION USING THE PADPRO 2001Z-PC, ONE HAD A SUPERFICIAL BURN.¿ 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: Superficial (First Degree) Burn
MAUDE report 21433153 ↗

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	`10653405042495`
Brand	PadPro
Model	2001Z-PC
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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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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