Bio-Console® R560BCS1 (UDI 00613994450319)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994450319), received between Jun 14, 2022 and Aug 26, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Device Alarm System; Battery Problem

  Medtronic received information that at an unspecified time, this Bio-Console 560 instrument had an error code 69 (SC MPU UPS open battery detected hard error). The use of the instrument was unspecified. There was no adverse patient effect reported with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449255 ↗
• MalfunctionMar 24, 2026Power Problem

  IT WAS REPORTED THAT DURING THE ANNUAL PREVENTIVE MAINTENANCE INSPECTION OF THE BIO-CONSOLE 560 CONTROLLER INSTRUMENT THE INSTRUMENT KEPT ALARMING "AC POWER FAILURE" WHEN PLUGGED INTO AC POWER. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672339 ↗
• MalfunctionJan 10, 2025Battery Problem; Battery Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT FAILED THE BATTERY VOLTAGE TEST. IT MEASURED 11.4V WHEN IT SHOULD BE AT LEAST 12.75V. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130351 ↗
• MalfunctionApr 12, 2024Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE BASE HAD AN INTERMITTENT ENERGY FAILURE ALARM. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094589 ↗
• MalfunctionSep 19, 2023Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIOCONSOLE 560 INSTRUMENT, IT WAS REPORTED THE OCCURRENCE OF A LOW BATTERY ERROR MESSAGE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERIES WERE 3YRS OLD AND THE LOT NUMBER WAS 080521-LM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773238 ↗
• MalfunctionJun 30, 2023Pumping Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-CONSOLE BASE INSTRUMENT, THE CUSTOMER REPORTED THAT THERE WAS AN INCIDENT AND THIS INSTRUMENT STOPPED OXYGENATING BLOOD FOR A FEW MINUTES. USE OF THE INSTRUMENT WAS CONTINUED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS WAS ASKED BUT UNKNOWN, HOWEVER THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CUSTOMER DID NOT REQUIRE THE HAND CRANK, AT ANY STAGE. THE AMOUNT OF TIME THE INSTRUMENT STOPPED OXYGENATING BLOOD WAS REQUESTED BUT IT WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238932 ↗
• MalfunctionJun 8, 2023Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT IT DID NOT CHARGE THE BATTERIES. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086209 ↗
• MalfunctionMay 2, 2023Display or Visual Feedback Problem; Power Problem; Display or Visual Feedback Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT THERE WAS NO DISPLAY ON THE USER INTERFACE (UI) AND BASE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16851730 ↗
• MalfunctionJun 14, 2022Power Problem; Pressure Problem; Power Problem; Pressure Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT'S POWER SUPPLY VOLTAGE WAS FLUCTUATING BETWEEN 26VDC-29VDC AND THE INSTRUMENT FAILED THE PRESSURE LEAK TEST. THE INITIAL PROBLEM WAS THE FLUCTUATING POWER SUPPLY VOLTAGE. ONCE THAT WAS REPAIRED, THE TECHNICIAN CONDUCTED FURTHER TESTING OF THE DEVICE AND STARTED THE LEAK TEST, A 1000MMHG PRESSURE WAS INJECTED INTO THE BP PORTS TO MAINTAIN A PRESSURE FOR A LONG PERIOD OF TIME. THE PRESSURE BOARD DID NOT HOLD PRESSURE, WHICH INDICATES A LEAK IN THE SYSTEM. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14683551 ↗