STANDARD CAPACITY BATTERY MODULE FOR CENTRIMAG BACK-UP CONSOLE 102958Recalls & reported problems
Thoratec Switzerland GmbH · 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 07640135140528), received between Sep 17, 2021 and Mar 24, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 /Electronic Property Problem1
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2022Noise, Audible; Noise, Audible
IT WAS REPORTED THAT THE LVAD CIRCUIT WAS EXCHANGED. THE NURSES NOTED A CLICKING ON AND OFF. THE CLICKING WAS RHYTHMIC. RELATED MANUFACTURER REFERENCE REPORT # 3003306248-2022-00047.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13892312 ↗MalfunctionSep 17, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE CENTRIMAG WAS UNPLUGGED AND TAKEN INTO THE CATHETERIZATION LABORATORY. WHEN THE PRIMARY CONSOLE WAS TURNED ON, THE ERROR MESSAGE B1 FOR THE BATTERY MODULE WAS SEEN. THE PRIMARY CONSOLE WAS THEN SWITCHED TO THE BACKUP CONSOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12490317 ↗
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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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