STAT-PADZ II 8900-0801-01Recalls & reported problems

Zoll Medical Corporation · STAT*PADZ II ADULT MULTI-FUNCTION ELECTRODES (1 PAIR) · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 1
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847946016326), received between Jun 26, 2017 and Dec 5, 2024 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (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

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

Most reported problems

Device problems

Unable to Obtain Readings2
Device Operational Issue1
Patient Device Interaction Problem1
Tear, Rip or Hole in Device Packaging1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Burn(s)1
Insufficient Information1
No Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

DeathDec 5, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE PADS WERE MISSING THE FILMS BETWEEN THE CARDBOARD AND THE GEL AFTER OPENING/REMOVAL OF PACKAGING. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Insufficient Information
MAUDE report 20858043 ↗
MalfunctionMar 17, 2023Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16567438 ↗
MalfunctionMar 9, 2023Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIFBRILLATOR DISPLAYED A "PLUG IN CABLE" MESSAGE WHEN THESE ELECTRODE PADS WERE ATTACHED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16516220 ↗
InjurySep 5, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED BURNS. THIS IS ALL THE INFORMATION AVAILABLE.
Patient problems: Burn(s)
MAUDE report 8966566 ↗
MalfunctionJun 26, 2017Device Operational Issue; Device Operational Issue
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), UPON OPENING THE ELECTRODE PAD'S PACKAGING THE WIRES WERE DISLODGED. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 6666543 ↗

Device details

UDI-DI	`00847946016326`
Brand	STAT-PADZ II
Model	8900-0801-01
Company	Zoll Medical Corporation
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Feb 3, 2026

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 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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