AED PLUSRecalls & reported problems across all models
Zoll Medical Corporation · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one AED PLUS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,966
- Deaths reported
- 37
- Injuries reported
- 5
- Recalls
- 1
We found 30 models of AED PLUS by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 1,966 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2015 and Sep 29, 2026 — classified as 37 deaths, 5 injuries, 1,924 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (1,080 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
AED PLUS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 12, 2019Open, Classified
There is a potential for the device to fail to deliver energy to the patient.
Z-1931-2019 · Root cause: Device Design · Recall details · FDA record ↗
Most reported AED PLUS problems
Device problems
- Failure to Power Up1,080
- Failure of Device to Self-Test540
- Incorrect Interpretation of Signal59
- Unexpected Shutdown49
- Unable to Obtain Readings44
- Use of Device Problem31
- Failure to Cycle29
- Failure to Deliver Shock/Stimulation23
Patient problems
- No Clinical Signs, Symptoms or Conditions947
- No Patient Involvement863
- Insufficient Information52
- No Information41
- No Consequences Or Impact To Patient23
- Necrosis16
- Death13
- Cardiac Arrest4
AED PLUS models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AED PLUS 20000000100011010Automated external defibrillators (non-wearable)16 deaths1,072 reports
- AED PLUS 20000700700011010Automated external defibrillators (non-wearable)8 deaths426 reports
- AED PLUS 20000800100011010Automated external defibrillators (non-wearable)4 deaths183 reports
- AED PLUS 20000000100011360Automated external defibrillators (non-wearable)2 deaths136 reports
- AED PLUS 70010400499991010Automated external defibrillators (non-wearable)1 recall1 report
- AED PLUS 20000000300011010Automated external defibrillators (non-wearable)2 deaths38 reports
- AED PLUS 20001100100011360Automated external defibrillators (non-wearable)24 reports
- AED PLUS 70000000102011010Automated external defibrillators (non-wearable)13 reports
- AED PLUS 20001100100011360Automated external defibrillators (non-wearable)11 reports
- AED PLUS 20000001100011010Automated external defibrillators (non-wearable)2 deaths6 reports
- AED PLUS 20000000100011100Automated external defibrillators (non-wearable)6 reports
- AED PLUS 20000100200000010Automated external defibrillators (non-wearable)5 reports
- AED PLUS 20000000100011260Automated external defibrillators (non-wearable)1 death5 reports
- AED PLUS 20000000100011230Automated external defibrillators (non-wearable)2 deaths5 reports
- AED PLUS 20100000102011010Automated external defibrillators (non-wearable)4 reports
- AED PLUS 22800810102011010Automated external defibrillators (non-wearable)4 reports
- AED PLUS 20000800300011010Automated external defibrillators (non-wearable)3 reports
- AED PLUS 70000000101011010Automated external defibrillators (non-wearable)3 reports
- AED PLUS 70010200499991010Automated external defibrillators (non-wearable)3 reports
- AED PLUS 20000000000000010Automated external defibrillators (non-wearable)2 reports
- AED PLUS 20000001300011010Automated external defibrillators (non-wearable)2 reports
- AED PLUS 70000000100011010Automated external defibrillators (non-wearable)2 reports
- AED PLUS 20000700700011230Automated external defibrillators (non-wearable)2 reports
- AED PLUS 70000700700011010Automated external defibrillators (non-wearable)2 reports
- AED PLUS 8000-004000-01Automated external defibrillators (non-wearable)2 reports
- AED PLUS 8000-004007-01Automated external defibrillators (non-wearable)2 reports
- AED PLUS 20000060100011010Automated external defibrillators (non-wearable)1 report
- AED PLUS 70000800100011010Automated external defibrillators (non-wearable)1 report
- AED PLUS 20100000302011010Automated external defibrillators (non-wearable)1 report
- AED PLUS 20000000100011360Automated external defibrillators (non-wearable)1 report
Recent AED PLUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934488 ↗MalfunctionSep 28, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915840 ↗MalfunctionSep 24, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882701 ↗MalfunctionSep 22, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855322 ↗MalfunctionSep 21, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839852 ↗MalfunctionSep 21, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839108 ↗MalfunctionSep 17, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804670 ↗MalfunctionSep 17, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE WOULD NOT POWER UP.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804325 ↗MalfunctionSep 16, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787484 ↗MalfunctionSep 15, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775585 ↗MalfunctionSep 14, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755884 ↗MalfunctionSep 14, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753798 ↗MalfunctionSep 10, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714000 ↗MalfunctionSep 8, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669928 ↗MalfunctionSep 8, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669918 ↗
Other Zoll Medical Corporation products
- R SERIES94 models · 8,522 reports
- X SERIES163 models · 6,915 reports
- 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
- 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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