Lifeline ECGRecalls & reported problems across all models
Defibtech, L.L.C. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Lifeline ECG model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Lifeline ECG by Defibtech, L.L.C. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between May 7, 2026 and Sep 8, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (2 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
Lifeline ECG 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.
- Mar 18, 2025Open, Classified
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Z-1693-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported Lifeline ECG problems
Device problems
- Premature Discharge of Battery2
- Failure to Deliver Shock/Stimulation1
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Lifeline ECG models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lifeline ECG DDU-E2450Automated External Defibrillators (Non-Wearable)1 recall1 report
- Lifeline ECG DDU-A2450Automated External Defibrillators (Non-Wearable)3 reports
Recent Lifeline ECG adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Failure to Power Up
A customer reported that their AED's ASI is blank, and the AED will not power on. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672556 ↗MalfunctionJul 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054222 ↗MalfunctionJun 20, 2026Premature Discharge of Battery
A CUSTOMER REPORTED THAT UPON INSERTING A NEW BATTERY PACK, THEIR AED POWERED ON AND PROMPTED A SERVICE CODE. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571633 ↗MalfunctionMay 7, 2026Failure to Deliver Shock/Stimulation
A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED, AND THE DEVICE IS REPORTING A SERVICE CODE. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112101 ↗
Other Defibtech, L.L.C. products
- Lifeline Configuration2 models · 1,754 reports · 1 recall
- Lifeline2 models · 817 reports · 2 recalls
- Lifeline Auto Configuration2 models · 430 reports
- Lifeline View Configuration2 models · 335 reports · 1 recall
- Lifeline Auto2 models · 218 reports
- Lifeline View2 models · 119 reports · 1 recall
- Defibtech ACC Configuration2 models · 80 reports
- Lifeline ECG Configuration2 models · 9 reports · 1 recall
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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