PRO PADZ 8900-2101-01Recalls & reported problems
Zoll Medical Corporation · ELECTRODES, PRO-PADZ CARDIOLOGY W/LVP GEL, SINGLE · Class 3
All models of PRO PADZ (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847946016395), received between Apr 8, 2020 and Jan 30, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem2
- Arcing of Electrodes1
Patient problems
- Burn(s)1
- Insufficient Information1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT DURING OPEN HEART SURGERY (AGE & GENDER UNKNOWN), TEGADERM (FILM DRESSING) IS APPLIED OVER THE PRO-PADZ. AFTER REMOVING THE TEGADERM AND PRO-PADZ, TEARS WERE FOUND ON THE PATIENT'S SKIN. NO INFORMATION WAS PROVIDED ABOUT SUBSEQUENT TREATMENT FOR THE SKIN TEARS OBERVED.
Patient problems: Insufficient Information
MAUDE report 18606369 ↗InjurySep 21, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A (B)(6) YEAR-OLD MALE PATIENT, AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY SUSTAINED SECOND DEGREE BURNS.
Patient problems: Burn(s)
MAUDE report 12509352 ↗MalfunctionApr 8, 2020Arcing of Electrodes; Arcing of Electrodes
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN) DURING CARDIOVERSION, AN ARC WAS HEARD FROM THE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 9939000 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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