Bio-Console® 560BCS1 (UDI 00613994450463)Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00613994450463), received between Dec 5, 2016 and May 4, 2026 — classified as 8 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (59 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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT WOULD NOT POWER ON. 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 25073340 ↗
• MalfunctionApr 23, 2026Device Alarm System; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE (DURING SETUP) OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BASE UNIT DISPLAYED AN ERROR CODE 43 AFTER BOOTING UP - BATTERY CHARGE FAILURE. 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 24970990 ↗
• MalfunctionApr 16, 2026Device Alarm System

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT HAD AN ERROR 69 (SC MPU UPS OPEN BATTERY DETECTED HARD ERROR). THE INSTRUMENT HAS NOT BEEN IN USE FO THE PAST 12 MONTHS AND WAS NOT CONNECTED TO POWER SINCE. 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 24903275 ↗
• MalfunctionApr 16, 2026Device Alarm System; Electrical /Electronic Property Problem; Obstruction of Flow

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE INSTRUMENT HAD A DEFECTIVE M/P BOARD. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PRESSURE FAILURE CAUSED A HARD FAULT AND WOULD LIKELY HAVE STOPPED THE DEVICE. THERE WAS AN ERROR THAT CAME UP DURING THE PRESSURE TESTING STEP OF THE PM. THE BOARD COULD NOT BE CALIBRATED AND THE SYSTEM DELIVERED A HARD FAULT WHEN UNDER PRESSURE. THE FAULT WAS ERROR 66 OFFSET HARD ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903210 ↗
• MalfunctionFeb 16, 2026Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO CONSOLES 560 INSTRUMENT, IT WAS REPORTED THAT THIS UNIT HAD A BATTERY ISSUE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345533 ↗
• MalfunctionJan 9, 2026Connection Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS BIO-CONSOLE INSTRUMENT HAD ITS BUBBLE PORT WORKING INTERMITTENTLY. SITE TRIED MULTIPLE PROBES WITH NO CHANGE. 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 24017769 ↗
• MalfunctionDec 19, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THE OCCURRENCE OF ERRORS 69 AND 91 AFTER BOOTING UP. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBER OF THE BATTERY REMOVED IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849569 ↗
• MalfunctionDec 11, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING USE OF THE BIO-CONSOLE 560 INSTRUMENT, THERE WAS AN ALLEGATION THAT THE BATTERY WAS NOT CHARGING. THE INSTRUMENT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776994 ↗
• MalfunctionOct 30, 2025Device Alarm System; Power Problem; Device Alarm System; Power Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23422194 ↗
• MalfunctionSep 12, 2025Battery Problem; Power Problem; Battery Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 CONTROLLER INSTRUMENT HAD POWER SUPPLY AND SYSTEM CONTROLLER THAT WERE BAD, AND WERE NOT PROPERLY CHARGING THE BATTERIES. 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 23039013 ↗
• MalfunctionSep 8, 2025Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT HAD A POWER SUPPLY OUT OF CALIBRATION THAT NEEDED TO BE REPLACED. 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 22997698 ↗
• MalfunctionSep 2, 2025Battery Problem; Battery Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 CONTROLLER INSTRUMENT HAD A BATTERY ISSUE THAT REQUIRED REPLACEMENT. THE BATTERIES COULD NOT KEEP UNIT RUNNING DURING FUNCTION TEST. LOT 0011780938 WAS REMOVED AND REPLACED. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE REMOVED BATTERIES HAVE BEEN INSTALLED FOR TWO YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935980 ↗
• MalfunctionJul 24, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BATTERIES WOULD NOT CHARGE AND THE INSTRUMENT DID NOT POWER ON. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22593869 ↗
• MalfunctionJun 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THIS BIO-CONSOLE INSTRUMENT USER INTERFACE DISPLAY WAS BLANK AND THERE WAS A HOT SMELL COMING FROM THE BASE UNIT. INSTRUMENT WAS REPLACED WITH A BACKUP AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION RECEIVED FORM SERVICE, THERE WAS NO PROBLEMS FOUND WITH THE USER INTERFACE DURING MAINTENANCE. COMPLAINT IS AGAINST THE BASE ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22221438 ↗
• MalfunctionJun 4, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THE UNIT IS NOT HOLDING BATTERY 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 22141564 ↗
• MalfunctionMay 30, 2025Display or Visual Feedback Problem; Battery Problem; Display or Visual Feedback Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS BIO-CONSOLE INSTRUMENT'S PUMP WAS TURNING ON, BUT THE SCREENS ON BOTH THE CONSOLE BASE AND THE USER INTERFACE WERE NOT TURNING ON. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FAILURE WAS IN THE SYSTEM CONTROLLER BOARD. THE BATTERIES WERE ALSO DUE TO BE CHANGED ON THIS CYCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112943 ↗
• MalfunctionMay 21, 2025Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THE AC POWER FAILURE BUTTON ERROR APPEARED ON SCREEN. CUSTOMER WAS UNABLE TO CLEAR THE ERROR, AND THE POWER CORD ICON ALSO SHOWS YELLOW. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC SERVICE WAS CONTACTED TO PROVIDE LOCATION OF THE ISSUE ON THE DEVICE. THIS IS A GE BIOMED ACCOUNT, AND THEY DO NOT PAY FOR FIELD SERVICE CALLS. NO SERVICE WAS PERFORMED. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059989 ↗
• MalfunctionMay 9, 2025Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT THE SYSTEM PROMPTED AN ERROR SAYING "AC POWER FAILURE". ACCORDING TO BATTERY SYMBOL, BATTERY APPEARS TO BE CHARGING. IT IS UNKNOWN IF THE CUSTOMER TRIED SWAPPING POWER CABLES WITH ANOTHER AND IF POWER CABLE HAS ANY PHYSICAL DAMAGE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997782 ↗
• MalfunctionMay 9, 2025Battery Problem; Battery Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993552 ↗
• MalfunctionMay 8, 2025Battery Problem; Battery Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 CONTROLLER HAD A BATTERY ISSUE. ONE OF THE BATTERIES WAS UNDER THE MINIMUM REQUIRED CAPACITY. 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 21987927 ↗
• MalfunctionMay 8, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIOCONSOLE INSTRUMENT HAD THE CHARGE STATUS LED FLICKERING RAPIDLY. 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 21987585 ↗
• MalfunctionFeb 26, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THERE WAS AN MP BOARD ALARM. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DISPLAYED ALARM WAS "ERR 54: SC MPU MC SPEED_CONTROL_W HARD ERROR". MEDTRONIC'S SERVICE TEAM CONFIRMED THAT THIS ERROR WOULD LIKELY CREATE A FLOW ISSUE. THE CUSTOMER DID NOT MENTION THE NEED TO USE A HAND CRACK TO MAINTAIN THE PATIENT'S FLOW DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468706 ↗
• MalfunctionFeb 20, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT WHEN THE SYSTEM IS UNPLUGGED FROM WALL POWER, IT IMMEDIATELY POWERS OFF. CALLER REPORTED THAT THE THIRD PARTY VENDOR THEY WORK WITH, STATED THE BATTERY NEEDED TO BE REPLACED.. 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 21420268 ↗
• MalfunctionFeb 11, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE BIO-CONSOLE 560 INSTRUMENT WAS GIVING A BATTERY ERROR AND OPERATING IN BATTERY MODE DESPITE BEING PLUGGED IN. MULTIPLE OUTLETS WERE TESTED, BUT THE ISSUE PERSISTED. THE INSTRUMENT WAS REPLACED WITH A BACKUP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360441 ↗
• MalfunctionFeb 4, 2025Battery Problem; Battery Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 CONTROLLER INSTRUMENT HAD A BASE CHARGE LED THAT WAS FLICKERING RAPIDLY. 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 21302355 ↗