PadPro 2516ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405042525), received between Sep 12, 2022 and Sep 12, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K020203, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2022Pacing Asynchronously; Defective Component

  AN ELDERLY PERSON EXPERIENCED ATRIAL FIBRILLATION WHILE ON VACATION AND HE PRESENTED TO LOCAL CARDIOLOGIST FOR EVALUATION AND THEN PURSUED ELECTRICAL CARDIOVERSION. PATIENT WAS BROUGHT TO BRONCH ROOM, ATTACHED TO LIFEPAK. FIRST SET OF PATCHES DEFECTIVE WHERE THE ADHESIVE STUCK TO PAPER INSTEAD OF PATCH. RN REAPPLIED DIFFERENT SET OF PATCHES. PATIENT SEDATED AND LIFEPAK TURNED ON AND SYNCHED TO PATIENT'S RHYTHM. UPON CHARGING MACHINE, THE PATIENT HAD A SLIGHT CHANGE IN RHYTHM, CONTINUED IN ATRIAL FIBRILLATION (A-FIB). LIFE PAK UNSYNCHED WITH PATIENT. RN IMMEDIATELY DUMPED CHARGE AND PROCEDURE STARTED AGAIN. DOCTORS ARE IN ROOM AND PROCESS RESTARTED. THE LIFEPAK RESYNCHED AND CHARGED TO APPROPRIATE JOULES AND SYNCH WAS LOST AGAIN, CHARGE DUMPED. NEW PADS APPLIED AND CARDIOVERSION ATTEMPTED AND SUCCEEDED THIS TIME WITH NO LOSS OF SYNCH MODE FOR CARDIOVERSION. RN NOTED THERE HAD RECENTLY BEEN 6 TO 8 PAD SETS TOSSED DURING PREVIOUS PROCEDURES HOWEVER, NO DATES, NO LOT NUMBERS RETAINED. THE CARDIOPULMONARY LAB PERSONNEL RETAINED THESE 3 SETS IN THIS REPORT AND SAVED PACKAGES AND DEVICES WHICH ARE ALL THE SAME LOT NUMBER. NO PATIENT HARMS.

  Patient problems: Insufficient Information

  MAUDE report 15401222 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020203, P200004. One submission often covers many models, so check the product and lot details in each record.

• Z-0458-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
• Z-0457-2015 · Nov 6, 2014 · Terminated
  ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
• Z-0757-2007 · Mar 8, 2007 · Terminated
  PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA for: CONMED CORPORATION
• Z-0756-2007 · Mar 8, 2007 · Terminated
  PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for: CONMED CORPORATION Uti