PRO PADZRecalls & reported problems across all models
Zoll Medical Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 181
- Deaths reported
- 0
- Injuries reported
- 78
- Recalls
- 0
We found 6 models of PRO PADZ by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 181 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2017 and Jul 6, 2026 — classified as 78 injuries, 103 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (74 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PRO PADZ problems
Device problems
- Patient Device Interaction Problem74
- Sparking52
- Arcing of Electrodes14
- Noise, Audible11
- Compatibility Problem10
- Unable to Obtain Readings10
- Failure to Convert Rhythm8
- Failure To Adhere Or Bond5
Patient problems
- Burn(s)59
- No Information27
- Insufficient Information25
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient20
- Skin Tears9
- Superficial (First Degree) Burn7
- Abrasion2
PRO PADZ models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PRO PADZ 8900-4006Automated External Defibrillators (Non-Wearable)145 reports
- PRO PADZ 8900-2106-01Automated External Defibrillators (Non-Wearable)22 reports
- PRO PADZ 8900-2302-01Automated External Defibrillators (Non-Wearable)6 reports
- PRO PADZ 8900-2101-01Automated external defibrillators (non-wearable)3 reports
- PRO PADZ 8900-4006PULSE-GENERATOR, PACEMAKER, EXTERNAL3 reports
- PRO PADZ 8900-4055-40Automated external defibrillators (non-wearable)2 reports
Recent PRO PADZ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 6, 2026Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN); AFTER REMOVING THE ELECTRODE PADS, A SKIN BLISTER/TEAR WAS FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED A STERNAL SKIN TEAR. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25718134 ↗InjuryMay 13, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Burn(s)
MAUDE report 25161964 ↗InjuryMay 13, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE AND GENDER UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Burn(s)
MAUDE report 25161957 ↗InjuryMay 13, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE CARDIOVERTING A MALE PATIENT (AGE UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Burn(s)
MAUDE report 25161143 ↗InjuryMay 13, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE AND GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS.
Patient problems: Burn(s)
MAUDE report 25161137 ↗InjuryMay 13, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A FEMALE PATIENT (AGE UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS. MEDSUN REPORT #: (B)(4).
Patient problems: Burn(s)
MAUDE report 25161123 ↗InjuryMay 13, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Burn(s)
MAUDE report 25161042 ↗InjuryMay 13, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Burn(s)
MAUDE report 25161013 ↗InjuryMay 13, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS.
Patient problems: Burn(s)
MAUDE report 25159716 ↗InjuryMay 12, 2026Sparking; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Burn(s)
MAUDE report 25148757 ↗MalfunctionMay 11, 2026Sparking
COMPLAINANT ALLEGED THAT WHILE CARDIOVERTING A MALE PATIENT (AGE UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 25135140 ↗MalfunctionMay 7, 2026Sparking
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN), 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: Insufficient Information
MAUDE report 25111416 ↗MalfunctionApr 29, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 21-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA 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 25027769 ↗MalfunctionApr 16, 2026Sparking
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 69-YEAR-OLD MALE PATIENT, A SPARK WAS EMITTED FROM THE PADS.
Patient problems: Insufficient Information
MAUDE report 24897493 ↗MalfunctionMar 31, 2026Sparking
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED MINOR SKIN BURNS.
Patient problems: Superficial (First Degree) Burn
MAUDE report 24746833 ↗
Other Zoll Medical Corporation products
- R SERIES94 models · 8,522 reports
- X SERIES163 models · 6,915 reports
- AED PLUS30 models · 1,966 reports · 1 recall
- Z Vent6 models · 1,204 reports · 1 recall
- Model EMV+ Vent, Army, MRI3 models · 964 reports
- E SERIES160 models · 833 reports
- ONESTEP8 models · 586 reports
- M SERIES BIPHASIC59 models · 572 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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