Bio-Console® 560BCS1 (UDI 00763000135447)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00763000135447), received between Nov 20, 2020 and Dec 16, 2025 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 3, 2021Open, Classified

   An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.

   Z-1313-2021 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THIS UNIT DISPLAYED ERROR CODE 69 (SC MPU UPS OPEN BATTERY DETECTED HARD ERROR). USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817894 ↗
• MalfunctionOct 21, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT AN ERROR CODE 27 OCCURRED. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345307 ↗
• MalfunctionJun 17, 2025Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THIS BIO-CONSOLE INSTRUMENT REQUIRED SERVICING, DUE TO A BLACK SCREEN AFTER BOOTING. USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE PATIENT EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235382 ↗
• MalfunctionJun 17, 2025Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING SET-UP, THIS BIO-CONSOLE INSTRUMENT REQUIRED SERVICING, DUE TO A BLACK SCREEN AFTER BOOTING. USE OF THE INSTRUMENT WAS UNSPECIFIED AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22234237 ↗
• MalfunctionJun 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THIS BIO-CONSOLE INSTRUMENT WAS SMOKING AFTER POWER ON. USE OF INSTRUMENT WAS UNSPECIFIED AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22225541 ↗
• MalfunctionJun 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING SET UP OF THE BIO-CONSOLE INSTRUMENT IT WAS NOTED THAT THE INSTRUMENT WAS SMOKING AFTER POWER ON. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT. THE CUSTOMER STATED THAT THE ISSUE HAPPENED WHEN THE INSTRUMENT WAS TAKE FROM A COLD ROOM TO A 25¿ ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22223348 ↗
• MalfunctionJun 16, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BATTERY WAS NOT HOLDING EVEN THOUGH BATTERY INDICATOR SHOWED FULL CHARGE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209872 ↗
• MalfunctionJun 21, 2024Battery Problem; Connection Problem; Battery Problem; Connection Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT'S BATTERIES DID NOT DISCHARGE PROPERLY AND THE BLIND CONNECTOR WAS BROKEN.THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERY DID NOT REACH ITS EXPECTED SHELF LIFE. THE BATTERY HAD BEEN INSTALLED IN THE INSTRUMENT SINCE FEBRUARY 18TH, 2022. THE LOT NUMBER OF THE BATTERY REMOVED FROM THE INSTRUMENT WAS #13458945.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581148 ↗
• MalfunctionApr 9, 2024Obstruction of Flow; Noise, Audible; Obstruction of Flow; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS BIO-CONSOLE 560 INSTRUMENT WAS NOISY AND THE MOTOR DID NOT RUN AT THE PROGRAMMED REVOLUTIONS. 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 19069445 ↗
• MalfunctionMar 14, 2024Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIOCONSOLE 560 INSTRUMENT HAD THE CHARGE INDICATING LIGHT ON THE FRONT KEYPAD WAS NOT WORKING. 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 18901432 ↗
• MalfunctionFeb 28, 2024Material Deformation; Power Problem; Material Deformation; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT IT HAD A FAILED MOTOR AND DAMAGED COMPONENT WHEN MOTOR WAS CONNECTED.THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18795740 ↗
• MalfunctionFeb 15, 2024Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE INSTRUMENT, THE CUSTOMER REPORTED THAT THE USER INTERFACE WAS DISPLAYING HARD ERROR CODE 54 RPM/MOTION AND PRESSURE MODULE. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709811 ↗
• MalfunctionJan 11, 2024Device Alarm System; Electrical /Electronic Property Problem; Smoking; Power Problem; Device Alarm System; Electrical /Electronic Property Problem; Smoking; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THIS BIO-CONSOLE 560 INSTRUMENT ALARMED WHEN IT POWERED ON AND IT WOULD NOT WORK. THE CUSTOMER STATED THAT THE BLOOD CONTROL AND DETECTION SYSTEM WERE ALSO FAULTY. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AFTER TURNING ON THE POWER, THE CUSTOMER OBSERVED SMOKE COMING FROM THE INSTRUMENT. THE CUSTOMER STATED THAT THERE WAS NO POWER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490777 ↗
• MalfunctionDec 18, 2023Device Alarm System; Device Alarm System

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIOCONSOLE 560 INSTRUMENT DISPLAYED AN ERROR 7 THAT WOULD NOT CLEAR. 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 18344991 ↗
• MalfunctionDec 11, 2023Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIOCONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BATTERY COULD NOT SUPPLY POWER. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERY BEEN INSTALLED IN THE INSTRUMENT FROM 2019.2.22

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302823 ↗
• MalfunctionJul 5, 2023Failure to Power Up; Failure to Power Up

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, DURING PRIMING OF THIS BIO-CONSOLE INSTRUMENT THERE WAS A REPORT OF A 'FATAL ERROR' ON INSTRUMENT. THE INSTRUMENT WAS CHANGED WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT. SERVICE GOT THE REP TO CLEAR THE ERROR MESSAGES WITH NO SUCCESS. THEY WERE UNABLE TO GET ANY RPM'S WITH THE EXTERNAL MOTOR DRIVE. THEY CHECKED THE CONNECTION AND REBOOTED THE INSTRUMENT. NEXT, THEY PLUGGED IN A 540T AND THE INSTRUMENT GOT UP TO 4500 RPM'S, BUT THEN GOT AN UNRECOVERABLE ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257989 ↗
• MalfunctionJul 5, 2023Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, DURING SET UP OF THIS BIO-CONSOLE BASE AND USER INTERFACE INSTRUMENT THE CUSTOMER NOTICED A SMOKE SMELL COMING FROM THE INSTRUMENT, THEY FELT LIKE IT WAS OVERHEATING AND IT DID NOT SHOW A DISPLAY. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254057 ↗
• MalfunctionJun 30, 2023Smoking; Smoking

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING SET UP THIS BIO-CONSOLE INSTRUMENT HAD A BURNING SMELL AFTER BOOT UP. THE INSTRUMENT WAS CHANGED WITH A BACKUP AND THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237107 ↗
• MalfunctionJun 30, 2023Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, DURING INSTALLATION THIS BIO-CONSOLE INSTRUMENT DISPLAYED ERROR 7 (AC POWER FAILURE). THIS WAS DETECTED DURING INSTALLATION SO THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236889 ↗
• MalfunctionJun 30, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE INSTRUMENT HAD A HARD SHUTDOWN WHEN CONTROL KNOB WAS TURNED TO MAXIMUM. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236833 ↗
• MalfunctionJun 23, 2023Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE USE OF THIS BIO-CONSOLE 560 INSTRUMENT THE CUSTOMER REPORTED THAT THE BATTERY DEFECTED. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERY DID CHARGE, AND THE BATTERY LIGHTS ARE WORKING. NO SPECIFIC COLOR FOR BATTERY LIGHT. THE BATTERY ICON WAS FULL ON THE DISPLAY SCREEN AND THE UNIT ONLY WORKED ABOUT ONE MINUTE WHEN POWER WAS SUPPLIED BY THE BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190388 ↗
• MalfunctionJun 23, 2023Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING SETUP THIS BIO-CONSOLE INSTRUMENT HAD A BROKEN SIGNAL CABLE AND DISPLAYED ERROR CODE 54 AFTER POWER ON. USE OF INSTRUMENT IS UNSPECIFIED AND THERE IS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189406 ↗
• MalfunctionJun 12, 2023Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT ERROR CODE 4 DISPLAYED AFTER BOOTING. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105390 ↗
• MalfunctionJun 6, 2023Smoking; Smoking

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE AFTER POWER ON THIS BIO-CONSOLE INSTRUMENT WAS SMOKING AND THERE WAS A PECULIAR SMELL. USE OF THE INSTRUMENT WAS UNSPECIFIED AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.   ADDITIONAL INFORMATION WAS REQUESTED FROM CUSTOMER ABOUT LENGTH OF DELAY CAUSED DUE TO THIS ISSUE AND THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069672 ↗
• MalfunctionMay 19, 2023Smoking; Smoking

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THIS BIO-CONSOLE INSTRUMENT WAS SMOKING AND GIVING OFF A BURNING SMELL AFTER BOOT UP. THE USER WAS NOT PUMPING FLUID WHEN THE INSTRUMENT WAS SMOKING. USE OF THE INSTRUMENT WAS UNSPECIFIED AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962246 ↗