NA 560A (UDI 00613994647832)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00613994647832), received between May 16, 2019 and Sep 2, 2025 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 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.

• MalfunctionSep 2, 2025Increased Pump Speed; Increased Pump Speed

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EXTERNAL MOTOR DRIVE INSTRUMENT, IT WAS REPORTED THAT THE REVOLUTIONS PER MINUTE (RPMS) UNEXPECTEDLY RAMPED UP. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE MOTOR RAMPED UP BEYOND THE RPM SETTING.THERE WERE NO SAFETY SYSTEMS IN USE AND THERE WAS NO ERROR OR WARNING MESSAGE. THERE WERE NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES WITH THE EXTERNAL DRIVE MOTOR/PUMP. THE FLOW TO THE PATIENT WAS ADDRESSED BY USING THE KNOB TO DECREASE THE RPMS TO THE DESIRED VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936734 ↗
• MalfunctionAug 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EXTERNAL MOTOR DRIVE INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT STOPPED WORKING. 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 22879769 ↗
• MalfunctionJul 15, 2025Mechanical Problem; Pumping Problem; Mechanical Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EXTERNAL MOTOR DRIVE, IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE INSTRUMENT NOT BLOCKING. THE INSTRUMENT HAD A LOOSE CONNECTION IN THE CABLE NEAR THE BLACK STRAIN RELIEVE AND DURING SOME MOVEMENT ON THE CABLE THE MOTOR WILL INCREASE OR DECREASE THE SPEED. 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 22506955 ↗
• MalfunctionMar 11, 2025Electrical /Electronic Property Problem; Material Deformation; Electrical /Electronic Property Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS BIO-CONSOLE 560 HAD AN ERROR CODE 52 (SC MPU MC SPEED CONTROL GAIN SOFT ERROR) AND THE EXTERNAL MOTOR DRIVE INSTRUMENT HAD A BROKEN CABLE AND WAS LOCKED SO COULD NOT BE USED. 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 21571648 ↗
• MalfunctionJan 29, 2025Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  IT WAS REPORTED THAT DURING USE OF THE EXTERNAL DRIVE MOTOR AND BIO-CONSOLE INSTRUMENT, THERE WAS UNEXPECTED MOTOR BEHAVIOR WHERE THE SYSTEM WAS SET TO 2200 RPM, BUT THE MOTOR WAS RUNNING AT 5000 RPM. USE OF THE INSTRUMENT WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262897 ↗
• MalfunctionNov 6, 2024Device Alarm System; Mechanical Problem; Device Alarm System; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A EXTERNAL DRIVE MOTOR INSTRUMENT, IT WAS REPORTED THAT THE MOTOR HEAD HAD A 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 20620437 ↗
• MalfunctionJul 2, 2024Pumping Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 EXTERNAL DRIVE MOTOR, IT WAS REPORTED THAT THE MOTOR WAS NOT WORKING AND THE RPM IS OFF. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656795 ↗
• MalfunctionJun 4, 2024Increased Pump Speed; Increased Pump Speed

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIOCONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE MOTOR RAMPED UP IN SPEED ON ITS OWN AND CREATED ERRORS 48 (SC MPU MC HALL PHASE B SOFT ERROR) AND 52 (SC MPU MC SPEED CONTROL GAIN SOFT ERROR) ON DISPLAY. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458357 ↗
• MalfunctionFeb 13, 2024Pumping Problem; Noise, Audible; Pumping Problem; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EXTERNAL DRIVE MOTOR, IT WAS REPORTED THAT THERE WERE ROTATION ISSUES AND IT WAS NOISY. 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 18693579 ↗
• MalfunctionJul 19, 2023Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE BIO-CONSOLE BASE, EXTERNAL MOTOR DRIVE AND FLOW TRANSDUCER INSTRUMENTS A MOTOR CONTROLLER MALFUNCTION ERROR OCCURRED AND WAS NORMALIZED AFTER REPEATED REBOOTS. IN ADDITION, A BACK-FLOW ALARM OCCURRED SEVERAL TIMES ALTHOUGH THE FLOW ZERO SETTING WAS NORMALLY COMPLETED. THE BACK-FLOW LEVEL WAS SLOWLY NORMALIZED AUTOMATICALLY WITHOUT ANY OTHER MANIPULATION, BUT IT OCCURRED IRREGULARLY DURING SURGERY, CAUSING DIFFICULTY. THE CUSTOMER STATED THAT THEY COULD NOT UNDERSTAND WHY THE ERROR OCCURRED FREQUENTLY, EVEN THOUGH THERE WAS NO CAUSE FOR BACK-FLOW. THE CUSTOMER ALSO, STATED IT SLOWLY CAME BACK TO NORMAL IN APPROXIMATELY 3 MINUTES. THE INSTRUMENTS WERE REPLACED WITH BACK-UPS AND THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION RECEIVED CONFIRMS THERE WAS NO IMPACT TO THE PATIENT AND THE HAND CRANK WAS REQUIRED. THE CUSTOMER SAID THAT ¿MOTOR CONTROLLER MALFUNCTION¿ MESSAGE SUDDENLY APPEARED. THERE WERE NO EXTERNAL FACTORS. AFTER 1 TO 3 TIMES REBOOTING, THE ISSUE WAS SOLVED. ADDITIONALLY THERE WAS A SUDDEN BACKFLOW ALARM. PER THE ATTACHED FILE, BACKFLOW RANGE WAS ABOUT -2.09. THE CUSTOMER DID ZERO THE SETTING ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351302 ↗
• MalfunctionJun 30, 2023Mechanical Problem; Pumping Problem; Mechanical Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THIS 560A EXTERNAL DRIVE MOTOR INSTRUMENT WAS HAVING MECHANICAL ISSUES AND THE MOTOR WOULD NOT SPIN. THE INSTRUMENT WAS REPLACED WITH A BACKUP AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237115 ↗
• MalfunctionJun 30, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THIS EXTERNAL MOTOR DRIVE INSTRUMENT HAD A MOTOR FAILURE. USE OF THE INSTRUMENT WAS NOT CONTINUED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237095 ↗
• MalfunctionJun 2, 2023Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS EXTERNAL DRIVE MOTOR INSTRUMENT THE CONE DECOUPLED, THE CONE WAS CHANGED OUT IN 30 SECONDS, WHEN THE CONE WAS SEATED HOWEVER, THE RPMS WOULD NOT INCREASE WITH THE KNOB BEING TURNED. THE KNOB WAS TURNED BACK OFF PAST CLICK, AND TURNED AGAIN AND THE RPMS WOULD NOT INCREASE PAST 0. THIS WAS REPEATED FOUR TIMES BEFORE CHANGING THE MOTOR. THE MOTOR WAS TAKEN OFF THE BACKUP CIRCUIT AND PLUGGED IN, THE RPMS WERE INCREASED SUCCESSFULLY, AND THE PATIENT WAS BACK ON EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) AFTER 90 SECONDS. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE HAND CRANK WAS NOT REQUIRED AT ANY STAGE DURING THE SWAP OUT TO MAINTAIN FLOW. THE CLINICAL PROCEDURE IS CONFIRMED AS BEING ECMO, NO FURTHER INFORMATION IS AVAILABLE. IT IS UNKNOWN HOW LONG THE PATIENT WAS ON E CMO PRIOR TO PUMP HEAD AND MOTOR FAILURE. THE CONE/PUMP HEAD DECOUPLING AND THE FAILURE OF MOTOR A1620 IS ALL THAT CAN BE VERIFIED FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048808 ↗
• MalfunctionDec 7, 2022Pumping Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS BIO-CONSOLE EXTERNAL DRIVE MOTOR, IT WAS REPORTED THAT THE MOTOR WAS NOT STARTING NORMALLY. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE MOTOR WAS NOT STARTING NORMALLY, IT WAS DESCRIBED AS BEING SLUGGISH TO REACH RPM¿S. IT WAS BELIEVED TO BE A MALFUNCTION WITH THE MOTOR ITSELF NOT THE POWER GOING TO IT. THE EXTERNAL MOTOR WAS REPLACED WITH A SPARE EXTERNAL MOTOR AND ALL WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15930602 ↗
• MalfunctionAug 5, 2022Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE EXTERNAL DRIVE MOTOR INSTRUMENT, IT WAS REPORTED THAT THE EXTERNAL DRIVE MOTOR WAS MALFUNCTIONING. USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WITH THE EXTERNAL DRIVE MOTOR WAS IT WAS NOT WORKING WHEN CONNECTED TO THE 560 BIOCONSOLE. THERE IS NO ALLEGATION AGAINST THE CENTRIFUGAL PUMP. THE RPM SETTING DID NOT MATCH THE RPM DISPLAY AS IT DIDN'T SPIN AT ALL AS IT WAS NOT WORKING. THERE WAS NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES WITH THE EXTERNAL DRIVE MOTOR/PUMP. THE FLOW TO THE PATIENT WAS IMPACTED. THE ISSUE WAS ADDRESSED BY CHANGING THE DRIVER AND THE HAND CRANK WAS NOT REQUIRED TO MAINTAIN THE FLOW. THERE WAS NO ERROR WARNING MESSAGE THAT APPEARED. THERE WAS NO SAFETY SYSTEMS IN USE (LEVEL SENSOR, BUBBLE DETECTOR, AND/OR AUTOCLAMP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173469 ↗
• InjuryMay 24, 2022Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO CONSOLE INSTRUMENT AND EXTERNAL DRIVE MOTOR, IT WAS REPORTED THE BIO-CONSOLE INSTRUMENT STARTED ALARMING AND READING "MOTOR MALFUNCTION" AND THE RPMS INCREASED TO 6000+. DUE TO THIS, THE CONE DECOUPLED. AN ATTEMPT WAS MADE TO TURN THE RPMS DOWN AND THEN OFF USING THE CONTROL KNOB, HOWEVER, RPMS REMAINED OVER 6000. RPMS SLOWLY CAME DOWN TO 960 ON THEIR OWN WITH THE KNOB STILL IN THE OFF POSITION. THE PATIENT WAS CLAMPED OUT, THE CONE WAS RESEATED, AND THE CUSTOMER TRIED TO RE-ESTABLISH FLOWS. RPMS INCREASED BACK UP TO 6000 WITH NO FLOW TO THE PATIENT. ELECTRONIC CONNECTIONS WERE CHECKED, THE BIO-CONSOLE WAS POWERED OFF, AND THE CUSTOMER SIMULTANEOUSLY STARTED HAND CRANKING. CATH LAB PAGED PERFUSION BACK-UP, A NEW BIO-CONSOLE AND EXTERNAL DRIVE MOTOR WERE BROUGHT INTO THE ROOM. THE CONE WAS SWITCHED TO NEW EXTERNAL DRIVE MOTOR, ATTACHED TO THE NEW BIO-CONSOLE. FLOWS WERE REESTABLISHED TO 4 LPM AT 2880 RPMS. THE CUSTOMER CONTINUED TO WORK THROUGHOUT INCIDENT, THE LOWEST PATIENT MEAN ARTERIAL PRESSURE (MAP) WAS 45. THE PATIENT LOST PULSATILITY FOR 60 SECONDS, BUT REMAINED STABLE AFTER REINITIATING OF FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 14487968 ↗
• MalfunctionMar 16, 2022Display or Visual Feedback Problem; Pumping Problem; Display or Visual Feedback Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS BIO-CONSOLE 560 EXTERNAL DRIVE MOTOR, CUSTOMER REPORTED THAT WHEN THE PERFUSIONISTS SWITCHED THE KNOB, THERE WAS NO CHANGE IN RPM AND DISPLAY BUT WHEN THEY TOUCHED THE MOTOR DRIVE LINE MORE TIGHTLY THE RPM WORKED. THE INSTRUMENT WAS REPLACED WITH A BACKUP AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13786876 ↗
• InjuryDec 11, 2019Pumping Stopped; Pumping Stopped

  ADDITIONAL INFORMATION WAS RECEIVED THAT WHEN THE HEAD PUMP MALFUNCTIONED THERE WAS ALSO AN ATYPICAL NOISE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9449652 ↗
• InjuryMay 16, 2019Pumping Stopped; Pumping Stopped

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE THIS BIO-CONSOLE EXTERNAL DRIVE MOTOR INSTRUMENT FAILED TO START WHEN PERFUSIONIST TURNED RPM KNOB. THE INSTRUMENT WAS REPLACED WITH A BACK UP AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE BIO-CONSOLE INSTRUMENT HAD BEEN SET UP AND RECIRCULATED EARLIER IN THE DAY AND KEPT RUNNING FOR ABOUT 4 HOURS WHILE THEY WAITED TO INITIATE BYPASS WITH NO ISSUES NOTED. CUSTOMER NOTED PATIENT PRESSURE DROPPED TO ZERO, THEY HAD RPMS BUT NO FORWARD FLOW. CUSTOMER ATTEMPTED TO TROUBLESHOOT THE ISSUE AND THEN BEGAN TO HANDCRANK TO PRODUCE FORWARD FLOW AT ABOUT 2000 RPMS. CUSTOMER CHANGED OUT EXTERNAL DRIVE MOTOR BY SWAPPING OUT THE CABLES AND INITIATED CPB AGAIN AFTER FIVE MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616180 ↗