THORATEC RECHARGEABLE LI-ION BATTERY 201-50207Recalls & reported problems
Thoratec Switzerland GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640135140535), received between Mar 10, 2021 and Dec 23, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem3
- Nonstandard Device2
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING A ROUTINE CENTRIMAG BATTERY MAINTENANCE TEST, THE SYSTEM DID NOT PASS THE BATTERY TEST AND DISPLAYED A 'TEST FAILED' MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875951 ↗MalfunctionJan 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT A B1 ALARM ON THE CENTRIMAG II CONSOLE OCCURRED. THE CONSOLE BATTERY WAS REPLACED WITH NEW BATTERY, BUT THE ALARM RETURNED. RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-00008.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18459703 ↗MalfunctionJun 24, 2022Electrical /Electronic Property Problem; Improper or Incorrect Procedure or Method; Electrical /Electronic Property Problem; Improper or Incorrect Procedure or Method
RELATED MANUFACTURER REPORT NUMBER: 3003306248-2022-11288. IT WAS REPORTED THAT ON (B)(6) 2022 AROUND 11:00 AM, THE CENTRIMAG CONSOLE SCREEN SHOWED A B3 ALARM AFTER A SELF-TEST WAS PERFORMED. THE BATTERY WAS EXCHANGED IN ATTEMPT TO RESOLVE THE ALARM; HOWEVER, AFTER THE BATTERY WAS EXCHANGED AN S3 ALARM APPEARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14799063 ↗MalfunctionOct 13, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT DURING INSTALLATION OF NEW CENTRIMAG SYSTEM IT WAS FOUND THAT THERE WERE TWO BACKUP BATTERIES THAT ALREADY EXPIRED BACK IN (B)(6) 2020. THE BATTERIES WERE EXCHANGED. THE FIRST BATTERY PRODUCT WAS REFERENCED IN MANUFACTURER REPORT NUMBER# 3003306248-2021-04047.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12625829 ↗MalfunctionOct 13, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT DURING INSTALLATION OF NEW CENTRIMAG SYSTEM IT WAS FOUND THAT THERE WERE TWO BACKUP BATTERIES THAT ALREADY EXPIRED BACK IN (B)(6) 2020. THE BATTERIES WERE EXCHANGED. SECOND BATTERY PRODUCT WAS REFERENCED IN MANUFACTURER REPORT NUMBER # 3003306248-2021-04048.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12625810 ↗MalfunctionMar 10, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
RELATED MANUFACTURER REPORT NUMBER: 3003306248-2021-01070
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11454150 ↗
Other Control, Pump Speed, Cardiopulmonary Bypass devices
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- Bio-Console® 560BCS1Medtronic, Inc. · Control, pump speed, cardiopulmonary bypass1 recall1 death121 reports
- LifeSPARC 5900-0001Cardiacassist, Inc. · Control, Pump Speed, Cardiopulmonary Bypass2 recalls1 death5 reports
- CP5 Pump Control PanelLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall53 reports
- LifeSPARC 5900-0000Cardiacassist, Inc. · Control, Pump Speed, Cardiopulmonary Bypass2 recalls0 reports
- CP5 Drive UnitLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall32 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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