ONESTEPRecalls & reported problems across all models
Zoll Medical Corporation · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 586
- Deaths reported
- 22
- Injuries reported
- 42
- Recalls
- 0
We found 8 models of ONESTEP by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 586 adverse event reports in the FDA's MAUDE database, received between Aug 4, 2015 and Sep 30, 2026 — classified as 22 deaths, 42 injuries, 522 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (202 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 ONESTEP problems
Device problems
- Unable to Obtain Readings202
- Failure of Device to Self-Test97
- Patient Device Interaction Problem77
- Device Operational Issue36
- Device Displays Incorrect Message25
- Failure to Deliver Shock/Stimulation24
- Pacing Problem13
- Sparking11
Patient problems
- No Clinical Signs, Symptoms or Conditions232
- No Patient Involvement163
- Insufficient Information56
- No Information50
- Burn(s)30
- No Consequences Or Impact To Patient15
- Death12
- Necrosis9
ONESTEP models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ONESTEP 8900-0224-01Automated external defibrillators (non-wearable)15 deaths492 reports
- ONESTEP 8900-0223-01Automated external defibrillators (non-wearable)1 death34 reports
- ONESTEP 8900-000219-01Automated external defibrillators (non-wearable)4 deaths28 reports
- ONESTEP 8900-0221-01Automated external defibrillators (non-wearable)1 death16 reports
- ONESTEP 8900-000405-01Automated external defibrillators (non-wearable)1 death10 reports
- ONESTEP 8900-0222-01Automated external defibrillators (non-wearable)4 reports
- ONESTEP 8900-000420-01Automated external defibrillators (non-wearable)1 report
- ONESTEP 8900-0215-40Automated External Defibrillators (Non-Wearable)1 report
Recent ONESTEP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Unable to Obtain Readings
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), 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 50947537 ↗MalfunctionSep 22, 2026Patient Device Interaction Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 38-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Cardiac Arrest
MAUDE report 50853732 ↗MalfunctionSep 22, 2026Patient Device Interaction Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 38-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Cardiac Arrest
MAUDE report 50853710 ↗MalfunctionSep 21, 2026Patient Device Interaction Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A 38-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN. 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 50839557 ↗MalfunctionSep 17, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE ELECTRODE PADS.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804517 ↗MalfunctionSep 4, 2026Gel Leak; Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE AN 64-YEAR-OLD MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN AND GEL MIGRATION.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 50612976 ↗MalfunctionSep 4, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR FAILED SELF TEST.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50612234 ↗InjuryAug 28, 2026Patient Device Interaction Problem
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING AN 85-YEAR-OLD FEMALE PATIENT, 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 50497987 ↗MalfunctionAug 24, 2026Packaging Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PADS WOULD NOT DETACH FROM PLASTIC BACKING DURING OPENING/REMOVAL OF PACKAGING.COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 50406273 ↗MalfunctionAug 20, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50347166 ↗MalfunctionAug 17, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50275253 ↗MalfunctionAug 14, 2026Sparking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253535 ↗MalfunctionAug 12, 2026Patient Device Interaction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222274 ↗MalfunctionAug 11, 2026Gel Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208860 ↗MalfunctionAug 3, 2026Sparking; Patient Device Interaction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114542 ↗
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
- M SERIES BIPHASIC59 models · 572 reports
- Powerheart G5 Kit, Auto, US Eng/ESP LA2 models · 350 reports · 4 recalls
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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