Bio-Console® 560BC1Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00613994450326), received between Apr 6, 2023 and Aug 14, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255330 ↗
• MalfunctionJan 14, 2026Battery Problem

  IT WAS REPORTED THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, THE BATTERY NOT HOLDING A CHARGE. DURING TRANSPORT, THE BATTERY LASTED 10 MINUTES. 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 24065406 ↗
• MalfunctionDec 10, 2025Battery Problem; Battery Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 CONTROLLER INSTRUMENT HAD A BATTERY ISSUE, AS THE BATTERIES WERE NOT HOLDING CHARGE. 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 23768186 ↗
• MalfunctionSep 2, 2025Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE AC INDICATOR ON THE USER INTERFACE WAS FLUCTUATING ON AND OFF. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENT'S BASE POWER SUPPLY WAS FAILING. THE USER INTERFACE DID NOT EXPERIENCE A FAILURE. THE BATTERIES WERE FUNCTIONING PROPERLY AND WERE REPLACED DUE TO AGE, AS PART OF PREVENTIVE MAINTENANCE, AS THEY WERE INSTALLED FOR 4 YEARS. NO ABNORMAL ELECTRICAL EVENTS OCCURRED, NO DAMAGE WAS NOTED TO THE INSTRUMENT AND NO VISIBLE AIR WAS OBSERVED IN THE SYSTEM/TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936298 ↗
• MalfunctionJul 14, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE BASE INSTRUMENT, IT WAS REPORTED THAT THE BATTERY DIED AND IT WOULD NOT CHARGE BACK UP. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493017 ↗
• MalfunctionJun 26, 2025Battery Problem; Battery Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE'S BASE LED BATTERY CHARGE INDICATOR 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 22334464 ↗
• MalfunctionMay 26, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIOCONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BATTERY WAS NOT HOLDING CHARGE. 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 22084867 ↗
• MalfunctionNov 12, 2024Battery Problem; Power Problem; Battery Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE INSTRUMENT WAS NOT PASSING UNINTERRUPTIBLE POWER SUPPLY (UPS) TEST, CHARGE CURRENT WAS FLUCTUATING SPORADICALLY UP AND DOWN IN VALUE. 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 20661977 ↗
• MalfunctionNov 6, 2024Increase in Pressure; Battery Problem; Increase in Pressure; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THE BATTERY WAS NOT HOLDING CHARGE AND DIES WHEN UNPLUGGED. AND THE PRESSURE SENSOR SEEMS TO READ TOO HIGH ACCORDING TO THE USER. 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 20621353 ↗
• MalfunctionOct 31, 2024Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT HAD A DEFECTIVE POWER SUPPLY. 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 20578720 ↗
• MalfunctionOct 31, 2024Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT HAD A DEFECTIVE POWER SUPPLY. 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 20578628 ↗
• MalfunctionSep 11, 2024Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THE BATTERIES WERE 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 20189016 ↗
• MalfunctionJul 15, 2024Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BATTERIES IS NOT HOLDING CHARGE. DURING TRANSPORTATION THE BATTERY WILL NOT LAST VERY LONG, AND HAD TO BE ABORTED. THE UNIT WAS PLUGGED BACK INTO AC POWER. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERY WAS INSTALLED ON AUGUST 2023. AND THE LOT NUMBER OF THE BATTERY REMOVED FROM THE INSTRUMENT IS 0011193821. THE DISPLAYED BATTERY CHARGE INDICATOR AND BATTERY ALARMS WERE WORKING APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740438 ↗
• MalfunctionMay 14, 2024Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT HAD A POWER SUPPLY VOLTAGE FLUCTUATING BETWEEN 26-28VDC. 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 19310550 ↗
• MalfunctionMay 9, 2024Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE, IT WAS REPORTED THAT THE INSTRUMENT HAD A BAD BATTERY. 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 19276815 ↗
• MalfunctionFeb 9, 2024Device Alarm System; Power Problem; Device Alarm System; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT SAID "COMMUNICATION LOST". THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A HAND CRANK WAS NOT REQUIRED TO MAINTAIN FLOW TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18674190 ↗
• MalfunctionAug 23, 2023Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT HAD A LOW BATTERY ISSUE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERY DID FAIL. THE CUSTOMER WAS UNSURE IF THE BATTERY HAD A DEFECT VERSUS A FAILURE TO DO WITH IMPROPER CHARGING CAUSING THE BATTERY TO DEGRADE PREMATURELY. SERVICE VERIFIED THE PROPER OPERATION OF THE POWER SUPPLY, PROPER OPERATION OF THE UNINTERRUPTED POWER SUPPLY BY SWITCHING VIA THE SERVICE MODE, THE PROPER OPERATION OF THE ON SCREEN DISPLAY DISPLAYING THE CORRECT WARNING AND ICONS AS THE POWER WAS SWITCHED FROM AC TO BATTERY AND THE PROPER OPERATION OF THE LED INDICATOR ON THE BASE WHEN SWITCHING BETWEEN AC POWER AND BATTERY POWER. THE BATTERY READ ABOVE 12.75VDC, UPON REPLACEMENT OF THE BATTERY, THE INSTRUMENT WAS RUN FOR 20 MINUTES WITH NO LOW BATTERY WARNING. THE LOT NUMBER OF THE REMOVED BATTERY IS 0011198399.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17601813 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS BIO-CONSOLE BASE INSTRUMENT AND USER INTERFACE, DURING SET-UP THE CUSTOMER INCREASED THE RPM KNOB FROM THE ZERO/OFF POSITION BUT THE MOTOR DID NOT SPIN. THE CUSTOMER TRIED MULTIPLE TIMES BUT HAD NO RESPONSE FROM THE MOTOR. THE BASE AND USER INTERFACE WERE REPLACED WITH A BACK UP AND THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECTS OCCURRED. ADDITIONAL INFORMATION: THE HAND-CRANK WAS NOT USED AS THIS INSTRUMENT WAS NEVER PLACED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254126 ↗
• MalfunctionJun 22, 2023Device Alarm System; Power Problem; Device Alarm System; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE INSTRUMENT, IT WAS REPORTED THAT THERE WERE ALARMS OF AC POWER FAILURE WHEN PLUGGED INTO A GOOD AC OUTLET. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181240 ↗
• MalfunctionJun 2, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN ON THIS BIO-CONSOLE INSTRUMENT IT WAS NOTED THAT THE POWER SUPPLY OUTPUT VOLTAGE WAS FLUCTUATING 0.5 TO 0.75 VOLTS OF THE SET POINT. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048667 ↗
• MalfunctionApr 6, 2023Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE INSTRUMENT HAD AC POWER FAILURE UPON BOOTUP. 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 16687781 ↗