PRO PADZ 8900-4006 (UDI 00847946016463)Recalls & reported problems
Zoll Medical Corporation · PRO*PADZ SOLID GEL RADIOLUCENT MULTI-FUNCTION ELECTRODES - 1 PAIR · Class 2
All models of PRO PADZ (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847946016463), received between Apr 9, 2024 and Aug 12, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Sparking” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Sparking3
- Compatibility Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2025Sparking; Sparking
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A 64-YEAR-OLD MALE PATIENT, THE DEVICE SPARKED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22786801 ↗MalfunctionJun 26, 2025Sparking; Compatibility Problem; Sparking; Compatibility Problem
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A MALE PATIENT (AGE UNKNOWN), THE ELECTRODE PADS SPARKED BURNING THE PATIENT. THE PATIENT'S SKIN IS RED BUT NOT BLISTERED. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341251 ↗MalfunctionApr 9, 2024Sparking; Sparking
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), A SPARK 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: Insufficient Information
MAUDE report 19069869 ↗
Other PULSE-GENERATOR, PACEMAKER, EXTERNAL devices
- NA 5392Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL1 death1,934 reports
- NA 5392Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL2 deaths930 reports
- NA 5392Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL2 deaths654 reports
- NA 5392Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL504 reports
- NA 53401Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL133 reports
- SoloPace EPG SOLOEPG1Solo Pace Inc. · Pulse-Generator, Pacemaker, External5 reports
- Solo Pace Control System SOLOEPG1LSolo Pace Inc. · Pulse-Generator, Pacemaker, External5 reports
- 5391Oscor Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL1 death2 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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