Lucas Battery Pack 11576Recalls & reported problems
Jolife AB · LUCAS 2 BATTERY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00883873970904), received between Mar 2, 2019 and Mar 16, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical Overstress” (1 report).
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.
Most reported problems
Device problems
- Electrical Overstress1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2023Electrical Overstress; Electrical Overstress
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S BATTERY BATTERY CAUGHT FIRE. THIS MAY LEAD TO INJURY AS A RESULT OF THE FIRE. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16557088 ↗MalfunctionMar 2, 2019Leak/Splash; Leak/Splash
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR LUCAS 2 BATTERY HAD BURNED AND WAS EMITTING SMOKE INSIDE A CARRY BAG. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER¿S BATTERY, PHYSIO-CONTROL OBSERVED EVIDENCE OF MATERIAL LEAKAGE FROM THE CELLS OF THE BATTERY. PER THE CELL MATERIAL SAFETY DATA SHEET THESE MATERIALS INCLUDE FLAMMABLE ORGANIC SOLVENTS AND CORROSIVE IRRITANTS. THUS POTENTIAL HAZARDS INCLUDE CHEMICAL BURNS FROM CELL MATERIAL EXPOSURE TO SENSITIVE TISSUES (EYES, SKIN, RESPIRATORY, GASTRO/RESPIRATORY) AND FOR THERMAL BURNS RESULTING FROM IGNITION OF VENTED BATTERY CELL FLAMMABLE SOLVENTS.
Patient problems: No Patient Involvement
MAUDE report 8384312 ↗
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- LUCAS 99576Jolife AB · Compressor, cardiac, external2 recalls9 deaths99 reports
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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