NA 560A (UDI 00763000108281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000108281), received between Mar 20, 2020 and May 22, 2025 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (6 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Pumping Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS EXTERNAL MOTOR DRIVE'S MOVEMENT WAS BLOCKED.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 22068118 ↗
• InjuryFeb 12, 2025Pumping Problem; Pumping Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362943 ↗
• MalfunctionOct 16, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EXTERNAL DRIVE MOTOR INSTRUMENT, IT WAS REPORTED THAT CARDIOPULMONARY BYPASS WAS INITIATED WITH FLOWS AT 2.1 INDEX. OVER THE NEXT 10 MINUTES FLOWS GRADUALLY DROPPED FOR NO APPARENT REASON. SURGEON WAS NOTIFIED. HE ORDERED BYPASS TERMINATED PUMP HEAD WAS RE-SEATED, LINES CHECKED, CANNULAS CHECKED. BYPASS REINITIATED BUT FLOWS STILL WOULD NOT COME 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 20461490 ↗
• MalfunctionSep 6, 2024Display or Visual Feedback Problem; Pumping Problem; Display or Visual Feedback Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING TESTING OF AN EXTERNAL MOTOR DRIVE INSTRUMENT, IT WAS REPORTED THAT WHEN THE MOTOR WAS TURNED ON, THE MAIN SCREEN WENT BLACK IMMEDIATELY AND THERE WAS A MOTOR DEFECT. 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 20154460 ↗
• InjuryJan 22, 2024Noise, Audible; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE EXTERNAL MOTOR DRIVE INSTRUMENT, IT WAS REPORTED THAT IT WAS MAKING A LOUD NOISE AT HIGH RPM. THE INSTRUMENT WAS REPLACED WITH A HAND CRANK BECAUSE OF THE NOISE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550787 ↗
• MalfunctionJan 15, 2024Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EXTERNAL DRIVE MOTOR, THE CUSTOMER REPORTED THAT BEFORE PREPARING TO SWITCH TO EXTRACORPOREAL MEMBRANE OXYGENATION, THE CUSTOMER FOUND THAT THE MOTOR WAS UNRESPONSIVE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AFTER THE EXTERNAL DRIVE MOTOR WAS CONNECTED TO THE 560 HOST, IT WAS CONFIRMED THAT THE POWER WAS TURNED ON, BUT AFTER THE PUMP HEAD WAS STUCK AND THE FLOW RATE WAS INCREASED, THERE WAS NO RESPONSE AND IT DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510311 ↗
• MalfunctionJan 8, 2024Device Alarm System; Power Problem; Device Alarm System; Power Problem

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS EXTERNAL DRIVE MOTOR HAD A MOTOR THAT DID NOT WORK AND THERE WERE ERROR CODES 37, 21 AND 19. 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 18463888 ↗
• MalfunctionAug 2, 2023Calibration Problem; Pumping Problem; Calibration Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EXTERNAL MOTOR DRIVE INSTRUMENT, THERE WAS A REQUEST FOR TEST OR CALIBRATION. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE MOTOR WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440968 ↗
• MalfunctionAug 1, 2023Obstruction of Flow; Noise, Audible; Obstruction of Flow; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EXTERNAL MOTOR DRIVE 560A INSTRUMENT, IT WAS REPORTED THAT THE THE CUSTOMER NOTICED A GRINDING NOISE WITH RATTLING COMING FROM THE EXTERNAL MOTOR DRIVE INSTRUMENT THAT WAS ON THE SOLARIS. THE CUSTOMER STATED THAT THE FLOW STARTED TO DECREASE SIGNIFICANTLY AND INCREASING THE RPMS DID NOT HELP. THE FLOW DECREASED FROM ABOUT 5 LPM TO ABOUT 3 LPM WITH MAXING OUT THE RPMS. THE CUSTOMER CLAMPED OUT FOR ABOUT 60 SECONDS AND SWAPPED TO ANOTHER EXTERNAL MOTOR DRIVE INSTRUMENT AND THEY DID NOT OBSERVE ANY FURTHER ISSUES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17433464 ↗
• MalfunctionJul 24, 2023Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING SETUP THE PUMP WOULD DECOUPLE FROM THE BIO-CONSOLE EXTERNAL MOTOR DRIVE INSTRUMENT. THE PROCEDURE WAS NOT COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378579 ↗
• MalfunctionJul 10, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-CONSOLE INSTRUMENT, EXTERNAL MOTOR DRIVE AND CENTRIFUGAL PUMP, THE MOTOR HEAD DECOUPLING SOUND BEGAN. THE CIRCUIT WAS CLAMPED, AND HAND CRANK INITIATED. THE PATIENT UNDERWENT CPR DUE TO NO FLOW. THE CIRCUIT WAS MOVED TO A NEW MOTOR DRIVE, AND THE NOISE CONTINUED. THE CUSTOMER SWITCHED TO A DIFFERENT MANUFACTURERS CENTRIFUGAL PUMP SYSTEM INCLUDING CIRCUIT TO ELIMINATE THE NOISE AND REMEDY FLOW. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT ANTI-COAGULATED DUE TO BLEEDING COMPLICATIONS AND A CLOT WAS EVIDENT INSIDE THE CENTRIFUGAL PUMP. THERE WAS NO VISIBLE DAMAGE TO THE CENTRIFUGAL PUMP. THE CUSTOMER STATED THAT THE CIRCUIT WAS IN USE FOR 329 HOURS PRIOR TO THE ISSUE AND THE FLOW RATE WAS AT 4.5LPM. THE CUSTOMER BELIEVES THAT DUE TO NO ANTI-COAGULATION, THE CLOT FORMED OVER THE EXTENDED PERIOD OF USE (329 HOURS). PATIENT STATUS IS UNKNOWN ALONG WITH PATIENT DATA DUE TO HIPPA REQUIREMENTS. ADDITIONAL INFORMATION: TUBING LOT#219975232 EUROSET OXYGENATOR LOT# 6362557F36 EUROSET OXYGENATOR IS NOT A MEDTRONIC PRODUCT. ACCORDING TO OUR SERVICE REP KRIS ASKAM ALL HARDWARE WAS IN SPEC AND WORKING CORRECTLY. THE ADVERSE EVENTS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286413 ↗
• MalfunctionJul 5, 2023Intermittent Communication Failure; Intermittent Communication Failure

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING PRE-OP, DURING USE OF A BIO-CONSOLE BASE, USER INTERFACE (UI), EXTERNAL MOTOR DRIVE AND FLOW TRANSDUCER AN ERROR MESSAGE APPEARED ON THE USER INTERFACE WHICH STATED COMMUNICATION TO BASE UNIT LOST, THE CUSTOMER NOTED THAT THE FLOW TRANSDUCER WAS BROKEN, THE DIAL ON THE UI WAS MOVING AT RANDOM, IT WAS NOT FIXED AND THE UI WAS NOT FIXED. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258007 ↗
• 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 17254099 ↗
• MalfunctionJul 4, 2023Obstruction of Flow; Noise, Audible; Obstruction of Flow; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS EXTERNAL DRIVE MOTOR FLOWS DROPPED AND THERE WAS A VIBRATION SOUND. INSTRUMENT WAS REPLACED WITH A BACKUP AND THERE IS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253842 ↗
• MalfunctionJul 3, 2023Power Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS BIO-CONSOLE EXTERNAL DRIVE MOTOR INSTRUMENT, IT HAD A SECTOR POWER FAILURE MESSAGE POP UP RANDOMLY. USE OF THE INSTRUMENT WAS UNSPECIFIED AND THERE WAS NO ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION REPORTED TO MEDTRONIC CONFIRMS THE HANDCRANK WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245117 ↗
• MalfunctionJun 1, 2023Obstruction of Flow; Noise, Audible; Obstruction of Flow; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE EXTERNAL DRIVE MOTOR INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT REQUIRED CONSUMABLES TO BE PREFILLED BEFORE PATIENT USE, AND THE MOTOR WAS NOISY, AND FLOW WAS AFFECTED. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO LEAKS WAS NOTED WITH THE INSTRUMENT. THE PUMP HAD BEEN IN USE DURING THE PREFILLED PROCESS, FOR ABOUT A FEW MINUTES, AND THERE WAS NO DAMAGE TO THE PUMP. THERE WAS NO VISIBLE AIR IN THE SYSTEM. THE CUSTOMER STATED THAT THEY ARE NOT REQUESTING REPAIR AS THE INSTRUMENT HAS BEEN REPLACED WITH ANOTHER MACHINE. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036834 ↗
• MalfunctionMar 3, 2022Pumping Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING SERVICING OF THIS BIO-CONSOLE EXTERNAL DRIVE MOTOR INSTRUMENT, IT WAS NOTED THAT OLD 540 HEAD NEEDED TO BE REPLACED WITH A NEW ONE AS IT WOULD NOT PUMP. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE DRIVE WAS SENT DIRECTLY TO THE CUSTOMER TO REPLACE THEMSELVES. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659820 ↗
• InjuryJun 17, 2021Pumping Problem; Noise, Audible; Pumping Problem; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE THIS BIO-CONSOLE MOTOR EXTERNAL DRIVE HAD A NOISE AND THE CUSTOMER THOUGHT THE PUMP DECOUPLED. THE NURSES WERE HAND CRANKING WHEN THE PERFUSIONIST ARRIVED. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12015286 ↗
• InjuryMar 20, 2020Pumping Stopped; Contamination /Decontamination Problem; Noise, Audible; Pumping Stopped; Contamination /Decontamination Problem; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-CONSOLE EXTERNAL MOTOR DRIVE AND A NON-MEDTRONIC POWER SUPPLY A HUMMING NOISE WAS NOTED TO BE COMING FROM THE EXTERNAL DRIVE MOTOR. THE NOISE STARTED TO GET PROGRESSIVELY LOUDER, BUT RPM AND ARTERIAL FLOW REMAINED UNAFFECTED AND THERE WAS HIGH VOLTAGE ERROR. THE CUSTOMER REQUESTED A BACKUP EXTERNAL DRIVE MOTOR AND GOT A HAND CRANK READY. THE CUSTOMER ASSUMED DECOUPLING OF THE DRIVE MOTOR AND CENTRIFUGAL PUMP, BECAUSE OF THE NOISE, AND THE CUSTOMER WAS ABOUT TO CLAMP, COME OFF CARDIOPULMONARY BYPASS (CPB), AND TURN RPM TO ZERO TO "RECOUPLE". AS SOON AS THE PERFUSIONIST WAS ABOUT TO DO THIS, THE DRIVE MOTOR FAILED, AND THE NOISE WENT AWAY. RPM WAS AT ZERO ON THE WORKSTATION BUT READING "!!!" ON THE NON-MEDTRONIC POWER SUPPLY, BACKFLOW WAS OBSERVED ON THE ARTERIAL LINE DUE TO NO RPM. THE CUSTOMER WAS UNABLE TO CONTROL THE RPM IN ANY WAY AND HAND CRANKING WAS STARTED. WHILE THE PERFUSIONIST WAS HAND CRANKING, THE EXTERNAL DRIVE MOTOR WAS UNPLUGGED FROM PORT 13, PLUGGED IT INTO PORT 1 4, RECONFIGURED THE ARTERIAL PUMP FOR LOCATION 14 IN ADMIN MODE, AND THE CUSTOMER WAS ABLE TO REGAIN CONTROL OF THE RPMS. HAND CRANKING WAS STOPPE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860296 ↗