Bio-Console® 560BCS1 (UDI 00763000236526)Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 00763000236526), received between Dec 22, 2020 and Sep 11, 2026 — classified as 1 death, 12 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (53 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Battery Problem

  Medtronic received information that prior to use of a Bio-Console 560 instrument, it was reported that the instrument did not operate on battery power. The instrument was replaced. There was no patient involvement, so no adverse effect occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728613 ↗
• MalfunctionSep 7, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50647475 ↗
• MalfunctionSep 2, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567283 ↗
• MalfunctionAug 4, 2026Device Alarm System; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130847 ↗
• MalfunctionMay 14, 2026Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A MOTOR CONTROLLER MALFUNCTION. 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 25169006 ↗
• MalfunctionApr 1, 2026Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A BATTERY FAILURE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758703 ↗
• MalfunctionMar 31, 2026Device Alarm System; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE BASE INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT DISPLAYED AN ERROR CODE 43 AFTER BOOTING UP. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739387 ↗
• MalfunctionJan 20, 2026Electrical /Electronic Property Problem; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE FLOW METER COULD NOT BE RESET TO ZERO.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 24113132 ↗
• MalfunctionDec 16, 2025Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BASE DISPLAY IS SOMETIMES BLACK. 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 23818332 ↗
• MalfunctionDec 10, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE (DURING SETUP) OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THE OCCURENCE OF ERROS CODE 1 (SC MPU CRC FATAL ERROR), 27 (SC MPU FS DEMODULATOR HARD ERROR, N2) AND 43 (SC MPU INTERNAL A/D -15V SUPPLY HARD ERROR). THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773907 ↗
• MalfunctionDec 8, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A BATTERY FAILURE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743991 ↗
• MalfunctionDec 8, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A BATTERY FAILURE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741386 ↗
• MalfunctionDec 8, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A BATTERY FAILURE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741297 ↗
• MalfunctionNov 7, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT IT DISPLAYED ERROR CODE 6(SC MPU EXTERNAL A/D CONVERTER -GAIN0 REFERENCE HARD ERROR), 7(SC MPU EXTERNAL A/D CONVERTER -GAIN1 REFERENCE HARD ERROR) AND 100 AFTER BOOTING UP. 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 23494447 ↗
• MalfunctionNov 4, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THE BATTERY FAILED. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467212 ↗
• MalfunctionNov 4, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THE BATTERY FAILED. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466980 ↗
• MalfunctionNov 4, 2025Display or Visual Feedback Problem; Battery Problem; Display or Visual Feedback Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A BATTERY FAILURE AND THAT THE BASE DISPLAY WAS BLANK. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465045 ↗
• MalfunctionNov 3, 2025Device Alarm System; Power Problem; Device Alarm System; Power Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE BIO-CONSOLE BASE, THE CLAMP MALFUNCTIONED AND ERROR CODES 99-SC MPU WATCHDOG TIMEOUT HARD ERROR <(>&<)> 100-SC MPU WATCHDOG POWER SUPPLY HARD ERROR WERE OBSERVED. A BACKUP DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448653 ↗
• InjuryOct 22, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THERE WAS ERROR CODE 7 (SC MPU EXTERNAL A/D CONVERTER -GAIN1 REFERENCE HARD ERROR) AFTER BOOTING, AND ERROR CODE 6 (SC MPU EXTERNAL A/D CONVERTER -GAIN 0 REFERENCE HARD ERROR),ERROR CODE 7 (SC MPU EXTERNAL A/D CONVERTER -GAIN1 REFERENCE HARD ERROR) AND ERROR CODE 100( SC MPU SS WATCHDOG TIMEOUT HARD ERROR) IN HISTORY LOG. 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 23355271 ↗
• MalfunctionOct 15, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, BATTERY FAILURE OCCURRED. THE INSTRUMENT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER INSTALL DATE IS (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277231 ↗
• MalfunctionOct 15, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, BATTERY FAILURE OCCURRED. THE INSTRUMENT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER INSTALLED DATE IS DECEMBER 22, 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277097 ↗
• MalfunctionSep 2, 2025Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT WAS WORKING INTERMITTENTLY. THE BATTERY INDICATOR ON THE SCREEN WOULD GO FROM GREEN TO YELLOW THEN BACK TO GREEN OR TO RED. 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 22943137 ↗
• MalfunctionSep 2, 2025Display or Visual Feedback Problem; Power Problem; Display or Visual Feedback Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THE BASE DISPLAY WAS BLANK. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938413 ↗
• MalfunctionSep 2, 2025Obstruction of Flow; Obstruction of Flow

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 HAD A MP BOARD VERIFICATION FAILURE. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO ERROR CODES WERE DISPLAYED. THE ISSUE WAS FOUND DURING VERIFICATION OF PRESSURE PORTS AND FLOW ADJUSTMENTS WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937228 ↗
• MalfunctionSep 2, 2025Display or Visual Feedback Problem; Battery Problem; Display or Visual Feedback Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT THE BASE UNIT DISPLAY WAS FLICKERING DURING OPERATION. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERIES WERE DEFECTIVE, WITH ONE SHOWING 12.7 V AND THE OTHER 12.1 V. THE BATTERIES HAD BEEN INSTALLED FOR OVER 4 YEARS, AND IT WAS NOT POSSIBLE TO OBTAIN THE LOT NUMBER AS THE INFORMATION WAS UNREADABLE. DURING MOTOR USE, THE BATTERIES LASTED 10 MINUTES AFTER THE INSTRUMENT WAS TURNED OFF. THE CUSTOMER WAS UNABLE TO SPECIFY WHY BATTERY POWER WAS REQUIRED. THE BATTERY ALARMS AND THE BATTERY CHARGE INDICATOR WERE OPERATING NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932053 ↗