NA 560BCS1Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00643169315822), received between Aug 29, 2018 and Sep 24, 2026 — classified as 8 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (57 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 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885523 ↗
• MalfunctionSep 9, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689947 ↗
• MalfunctionAug 14, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50250372 ↗
• InjuryMar 18, 2026Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560, IT WAS REPORTED AN ERROR 43 (SC MPU INTERNAL A/D -15V SUPPLY HARD ERROR) AFTER BOOTING UP. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631678 ↗
• MalfunctionMar 9, 2026Battery Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 CONTROLLER INSTRUMENT HAD A BATTERY ISSUE, AND REQUIRES REPLACEMENT DUE TO A LOW VOLTAGE ISSUE ON THE 2 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 24545173 ↗
• MalfunctionFeb 12, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE POTENTIOMETER WAS UNSTABLE, CAUSING UNSTABLE RPM. 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 24327072 ↗
• MalfunctionFeb 4, 2026Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 CONTROLLER INSTRUMENT, IT WAS REPORTED THAT THE SYSTEM HAD A BATTERY ISSUE AND THE BATTERY CABLE WAS BROKEN/ DISCONNECTED FROM THE BATTERY. 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 24258635 ↗
• MalfunctionJan 30, 2026Battery Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 CONSOLE INSTRUMENT HAD A BATTERY VOLTAGE BELOW 12.75VDC. 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 24221367 ↗
• MalfunctionJan 16, 2026Device Alarm System

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT HAD AN ERROR CODE74: SC MPU SS LEVEL DETECTOR 1 DISCONNECT HARD. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE OBSERVED ERROR 74 COULD HAVE AN IMPACT ON THE INSTRUMENT¿S POWER, VOLTAGE, OR FLOW AS THE CUSTOMER WOULD NOT BE ABLE TO USE THE LOW LEVEL SENSOR CABLE PRIOR TO THE REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091618 ↗
• MalfunctionJan 5, 2026Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BATTERY COULD NOT BE CHARGED. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957495 ↗
• MalfunctionDec 1, 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 CHARGING. 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 23678338 ↗
• MalfunctionNov 26, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT DURING PRIMING OF THE CIRCUIT, THE USER INTERFACE REPORTED THERE WAS A MOTOR ERROR (SC MPU MC SPEED_CONTROL_W HARD ERROR), SPEED CONTROL WITH HARD ERROR. THE CUSTOMER WAS ABLE TO REBOOT DEVICE AND ERROR DID NOT REPEAT. IT WAS USED IT FOR AN NORMOTHERMIC REGIONAL PERFUSION (NRP) ORGAN PROCUREMENT AS NO OTHER DEVICE WAS AVAILABLE. THE CUSTOMER DID NOT WANT TO CONTINUE TO USE THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655607 ↗
• MalfunctionNov 10, 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 USER INTERFACE DISPLAY COMES ON INTERMITTENTLY WHEN THE UNIT IS POWERED ON. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510752 ↗
• MalfunctionNov 10, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, THE UNIT WENT TO LOW BATTERY IMMEDIATELY WHEN UNPLUGGED. 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 23508354 ↗
• MalfunctionNov 4, 2025Power Problem; Power Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467680 ↗
• InjuryNov 4, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT BATTERIES DIED TOO QUICKLY DURING PATIENT TRANSPORT. 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 23465415 ↗
• MalfunctionOct 30, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BATTERIES WERE NOT HOLDING A CHARGE. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE REMOVED BATTERIES WITH LOT NUMBER 0011019087 HAVE BEEN INSTALLED SINCE 1ST APRIL 2022. BATTERY POWER WAS REQUIRED FOR PATIENT TRANSPORT. DISPLAY CHARGE INDICATOR AND BATTERY ALARMS WERE WORKING NORMALLY AND A HAND CRACK WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432797 ↗
• MalfunctionOct 20, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THERE WAS A BATTERY ISSUE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT WAS KNOWN THE BATTERY HAD A DEFECT BECAUSE WHEN UNIT UNPLUGGED FROM WALL THE DEVICE POWERS OFF. THE BATTERY HAD BEEN INSTALLED IN THE INSTRUMENT SINCE (B)(6) 2024.THE LOT NUMBER OF THE BATTERY REMOVED FROM THE INSTRUMENT WAS 0012054975

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334839 ↗
• MalfunctionSep 19, 2025Device Alarm System; Excess Flow or Over-Infusion; Obstruction of Flow; Noise, Audible; Device Alarm System; Excess Flow or Over-Infusion; Obstruction of Flow; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT DURING AORTIC SURGERY , THE PUMP WAS RUNNING AT APPROXIMATELY 2200¿2300 RPM. SUDDENLY, A LOUD ABNORMAL NOISE WAS HEARD, FOLLOWED BY A RAPID SURGE IN RPM. THIS EVENT CREATED A POTENTIAL RISK OF AN ABRUPT LARGE VOLUME BLOOD DELIVERY TO THE PATIENT. 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 23093248 ↗
• MalfunctionSep 15, 2025Battery Problem; Battery Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049599 ↗
• MalfunctionSep 8, 2025Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, AN AC POWER FAILURE WAS REPORTED DESPITE THE INSTRUMENT BEING PLUGGED INTO THE 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 22998394 ↗
• MalfunctionSep 8, 2025Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT WAS UNABLE TO ZERO FLOW OR READ FLOW. A DIFFERENT FLOW TRANSDUCER WAS TRIED, BUT IT WAS STILL UNABLE TO ZERO/READ FLOW. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998272 ↗
• MalfunctionAug 8, 2025Battery Problem; Battery Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS BIO-CONSOLE 560 REQUIRED A BATTERY REPLACEMENT.THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747098 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Obstruction of Flow; Infusion or Flow Problem; Fluid/Blood Leak; Obstruction of Flow; Infusion or Flow Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 CONTROLLER INSTRUMENT HAD A FLOW ISSUE, AND WILL NOT PASS FLOW CALIBRATION MEASUREMENTS. 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 22396333 ↗
• MalfunctionJun 24, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED AN ERROR CODE 43 (SC MPU INTERNAL A/D +15 V SUPPLY HARD ERROR). 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 22318857 ↗