LifelineRecalls & 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
2 open recalls name at least one Lifeline model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 817
- Deaths reported
- 3
- Injuries reported
- 2
- Recalls
- 2
We found 2 models of Lifeline by Defibtech, L.L.C. in the FDA's device registry (GUDID). Together they are named in 817 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2022 and Sep 30, 2026 — classified as 3 deaths, 2 injuries, 812 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (450 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 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-1690-2025 · Root cause: Process control · Recall details · FDA record ↗
- Feb 14, 2023Open, Classified
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
Z-1312-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Lifeline problems
Device problems
- Failure to Power Up450
- Premature Discharge of Battery274
- Battery Problem43
- Failure to Deliver Shock/Stimulation27
- No Audible Prompt/Feedback15
- Inaudible or Unclear Audible Prompt/Feedback6
- Audible Prompt/Feedback Problem2
- Defibrillation/Stimulation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions807
- Insufficient Information9
- Cardiac Arrest1
Lifeline models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lifeline DDU-100AAutomated External Defibrillators (Non-Wearable)1 recall3 deaths640 reports
- Lifeline DDU-100EAutomated External Defibrillators (Non-Wearable)1 recall177 reports
Recent Lifeline adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953769 ↗MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953768 ↗MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953765 ↗MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953764 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951838 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
A customer reported their AED's ASI is flashing red and prompting a "replace battery pack now" warning. The customer did not report this occurring during patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951837 ↗MalfunctionSep 29, 2026Failure to Power Up
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 50935602 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935601 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935600 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935599 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935597 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935596 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935595 ↗MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927997 ↗MalfunctionSep 29, 2026Failure to Power Up
An international distributor reported that their customer's AED would not power on; however, when tested with a spare battery pack, it did power 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 50927982 ↗
Other Defibtech, L.L.C. products
- Lifeline Configuration2 models · 1,754 reports · 1 recall
- 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
- Lifeline ECG2 models · 4 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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