BIO-PUMP+® 95201Recalls & reported problems
Medtronic, Inc. · PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994406941), received between Feb 20, 2017 and Feb 20, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “No Flow” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- No Flow1
Patient problems
- Coma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2017No Flow; No Flow
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 80 MINUTES INTO A CASE, THE CUSTOMER REPORTED THE FLOW FROM THIS BIOPUMP SUDDENLY WENT TO ZERO. THE CUSTOMER DID NOT USE THE HANDCRANK ON THE BIOCONSOLE AND PUT THE LINE IN THE ARTERIAL ROLLER IN THE CARDIOPULMONARY BYPASS MACHINE TO ADDRESS THE ISSUE. THE PATIENT WAS REPORTED TO BE IN A COMA, WITHOUT SEDATION, AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION: THE PATIENT WAS REPORTED TO HAVE PASSED AWAY ON (B)(6) 2017 FROM CARDIAC ARREST.
Patient problems: Coma
MAUDE report 6342854 ↗
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- Custom Perfusion System HY8L55R5Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE3 recalls3 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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