Bio-Console® R560BCS1 (UDI 00763000167325)Recalls & reported problems
Medtronic, Inc. · CONSOLE 560BCS1 CONTROL W/SAFETY BRD MEE · Class 2
All models of Bio-Console (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000167325), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Power 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Power Problem; Power Problem
MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS BIO-CONSOLE 560 CONTROLLER INSTRUMENT HAD A MOTOR FAILURE ERROR. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632006 ↗
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- Bio-Console® 560BCS1Medtronic, Inc. · Control, pump speed, cardiopulmonary bypass1 recall129 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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