Performer™ R5100052Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885074514857), received between Feb 22, 2022 and Aug 17, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Pumping Problem” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K052555); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Device Alarm System; Obstruction of Flow

  Medtronic received information that at an unspecified time, this Performer Console instrument had error codes and unstable flow measurement. 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 50270229 ↗
• MalfunctionJul 19, 2023Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PERFORMER, IT WAS REPORTED THAT PUMP 3 WAS NOT WORKING PROPERLY. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352105 ↗
• MalfunctionJul 19, 2023Power Problem; Power Problem

  DURING PREVENTIVE MAINTENANCE OF THIS PERFORMER INSTRUMENT, THE SERVICE TECHNICIAN NOTICED AN ISSUE ON THE RPM CONTROL OF THE EXTERNAL DRIVE MOTOR. THE SERVICE TECHNICIAN OBSERVED THAT THE MOTOR RANDOMLY STARTED TO SPIN BY ITSELF AT A SPEED <(><<)>500 RPM FOR ONE/TWO SECONDS EVEN WHEN THE CONTROL POTENTIOMETER WAS IN THE "OFF/DETENT" POSITION (MOTOR FULLY STOPPED). THE TECHNICIAN OBSERVED THAT THIS ISSUE HAPPENED TWO TO THREE TIMES IN A ROW AND FOR THE REST OF THE TIME, THE MOTOR REMAINED STEADY TO ZERO RPM. AS A PRECAUTION, THE SERVICE TECHNICIAN STOPPED THE PREVENTIVE MAINTENANCE AND THE INSTRUMENT HAS BEEN PLACED OUT OF ORDER AND THE CUSTOMER HAS BEEN INFORMED TO NOT USE THE INSTRUMENT. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE IS NO ALLEGATION AGAINST THE ETERNAL DRIVE MOTOR, THE ISSUE IS RELATED TO THE SPEED CONTROL CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350947 ↗
• MalfunctionJul 5, 2023Display or Visual Feedback Problem; Material Separation; Battery Problem; Material Deformation; Display or Visual Feedback Problem; Material Separation; Battery Problem; Material Deformation

  DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN ON THIS RETURNING LOANER INSTRUMENT IT WAS NOTED THAT THIS PERFORMER INSTRUMENT'S BATTERIES WERE DEEP DISCHARGED, THE INSERT AND SCREWS WERE DAMAGED, THE DISPLAY WAS OUT OF CALIBRATION, WRONG CHECK-SUM IMAGES WERE OBSERVED AND THE STATUS LAMP'S STICKY LABEL WAS LOOSE AND IT DID NOT FIT PROPERLY. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258058 ↗
• MalfunctionApr 5, 2023Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PERFORMER INSTRUMENT, IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED ISSUE. THE INSTRUMENT WAS USED TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CUSTOMER ALSO INDICATED THE FORWARD FLOW FROM THE CENTRIFUGAL PUMP APPEARED TO BE SLOWER THAN NORMAL AT THE DEFAULT RPM 39;S BEFORE GOING ON BYPASS. THE CUSTOMER HAD TO RAMP UP RPM 39;S A BIT HIGHER TO ACHIEVE HIGHER FLOWS WHEN THEY WENT ON BYPASS. CUSTOMER WAS ABLE TO MAINTAIN FULL FLOW AT DESIRED CARDIAC INDEX DURING THE CASE, TOWARDS THE END OF THE CASE AFTER THEY CAME OFF BYPASS, THE FORWARD FLOW SEEMED TO RESOLVE ITSELF AND RETURNED TO NORMAL, FORWARD FLOW APPEARED TO BE OK AT DEFAULT RPM 39;S AT THAT POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681189 ↗
• MalfunctionFeb 17, 2023Electrical /Electronic Property Problem; Pumping Problem; Electrical /Electronic Property Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A PERFORMER INSTRUMENT, IT WAS REPORTED THAT THE PUMP WAS SURGING UP TO 600 RPM WITH IT OFF AND WHEN ON IT WAS 0 RPM.  THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395082 ↗
• MalfunctionDec 20, 2022Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PERFORMER INSTRUMENT, IT WAS REPORTED THAT AFTER INITIATION OF BYPASS, SURGEONS CLAIMED THERE WAS NO BLOOD FLOW TO THE PATIENT. AFTER THIS INCIDENT, THE SURGICAL PROCEDURE (DOUBLE BYPASS AND AORTIC VALVE REPLACEMENT) WENT AS EXPECTED WITH THE SAME PUMP. THE PATIENT IS REPORTED TO BE SAFE, IN GOOD CONDITION, WITHOUT ANY ADVERSE EFFECTS. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AFTER DISCUSSIONS WITH THE SURGEON AND PERFUSIONIST, IT WAS DISCOVERED THAT THERE WAS CONTINUOUS BLOOD FLOW TO THE PATIENT (NEVER INTERRUPTED), BUT AT THE BEGINNING OF BYPASS THERE WAS A MOMENT WITH LOW FLOW, MOST LIKELY DUE TO RESISTANCE IN THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT (CANNULA MOVEMENT, ETC); THE CENTRIFUGAL PUMP DID NO STOP AND BLOOD WAS FLOWING CONTINUOUSLY. THE PATIENT SUFFERED NO HARM; WAS EXTUBATED IN THE INTENSIVE CAR UNIT (ICU) AND HAS BEEN DISCHARGED AND AT HOME IN GOOD CONDITION. THE HAND CRANK WAS NOT REQUIRED TO MAINTAIN FLOW. AN ERROR WARNING MESSAGE DID NOT APPEAR. THE SERVICE TECHNICIAN TRIED TO CHECK THE PERFORMER LOGS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014226 ↗
• MalfunctionMay 31, 2022Pumping Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THIS PERFORMER HAD A MASTER PUMP WHICH DID NOT STOP, IT REMAINED AT 300 GPM. AFTER THE PRIMING THE CUSTOMER NOTICED THAT IT WAS NOT POSSIBLE TO REACH A SPEED BELOW 300 RPM, THE CUSTOMER CONTINUED THE USE OF THE INSTRUMENT AND THE EXTRA-CORPOREAL CIRCULATION PROCEDURE WAS SUCCESSFULLY ENDED. WHEN THE CUSTOMER ENDED THE PROCEDURE THEY SWITCHED OFF AND SET APART THE INSTRUMENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS SUCCESSFULLY WEANED FROM BYPASS. THE SPEED OF THE PUMP COULD NOT BE R EDUCED BELOW 300 RPM, BUT DUE TO FEATURESOF THE CENTRIFUGAL PUMP, THE CUSTOMER WAS ABLE TO SUCCESSFULLY PERFORM THE WEANING, AS AT 300 RPM THERE IS NO FLOW TOWARDS THE OPERATORY FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548115 ↗
• InjuryFeb 25, 2022Pumping Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS PERFORMER INSTRUMENT, THE CUSTOMER REPORTED THAT PUMP 1 WAS INTERMITTENTLY NOT WORKING. THE INSTRUMENT PRIMED THE CARDIOPLEGIA PUMP AND DELIVERED THE FIRST RX CORRECTLY. THE SECOND DELIVERY STOPPED AT 100ML. THE CUSTOMER THEN HAD TO USE THE HAND-CRANK BEFORE RESTARTING THE INSTRUMENT WITH NO ISSUES. THE INSTRUMENT WAS REPLACED WITH A BACK UP AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION WAS REQUESTED TO CONFIRM HOW LONG THE HANDCRANK WAS IN USE FOR, HOWEVER THIS IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598959 ↗
• MalfunctionFeb 22, 2022Device Alarm System; Pumping Problem; Device Alarm System; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS PERFORMER INSTRUMENT, THE CUSTOMER NOTICED THAT THE INSTRUMENT WOULD NOT PRIME AND IT DISPLAYED A POSSIBLE ERROR MESSAGE OF "PUMP STOPPED". THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION RECEIVED CONFIRMS THE HAND CRANK WAS NOT REQUIRED TO MAINTAIN FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13575981 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052555. One submission often covers many models, so check the product and lot details in each record.

• Z-1090-2007 · Jun 4, 2007 · Terminated
  Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary