Terumo® Advanced Perfusion System 1 816572Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00886799001387), received between Jun 21, 2018 and Sep 23, 2026 — classified as 73 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (19 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 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Display or Visual Feedback Problem

  The Field Service Representative (FSR) reported that during preventative maintenance (PM) of the device the centrifugal control unit (CCU) display had missing pixels which caused it to be difficult to read. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870056 ↗
• MalfunctionMar 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CENTRIFUGAL CONTROL UNIT (CCU) HAD AN ISSUE. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24582843 ↗
• MalfunctionMar 10, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL CONTROL UNIT (CCU) REVOLUTIONS PER MINUTE (RPM) STAYED THE SAME AS THE TEAM WAS UNABLE TO GET A FLOW OF MORE THAN ONE LITER. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561153 ↗
• MalfunctionMar 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL CONTROL UNIT (CCU) DISPLAY DID NOT WORK PROPERLY MAKING IT DIFFICULT TO READ THE REVOLUTIONS PER MINUTE (RPM). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525856 ↗
• MalfunctionMar 5, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL CONTROL UNIT (CCU) HAD DECREASED FLOW AND WAS NOT ABLE TO GET MORE THAN AROUND 3.5 LITERS PER MIN (L/MIN) WITH A MAXED-OUT REVOLUTIONS PER MINUTE (RPM). THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525536 ↗
• MalfunctionNov 13, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR NON-CLINICAL ACTIVITY, THE CENTRIFUGAL CONTROLLER UNIT (CCU) DISPLAYED EITHER AN 'OVERSPEED' OR 'MOTOR STOP' MESSAGE. AS MITIGATION, MULTIPLE ADAPTER PLATES WERE USED BUT THE ISSUE REMAINED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23545692 ↗
• MalfunctionNov 13, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR NON-CLINICAL ACTIVITY, THE CENTRIFUGAL CONTROLLER UNIT (CCU) DISPLAYED EITHER AN 'OVERSPEED' OR 'MOTOR STOP' MESSAGE. AS MITIGATION, MULTIPLE ADAPTER PLATES WERE USED BUT THE ISSUE REMAINED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23545216 ↗
• MalfunctionSep 19, 2025Power Problem; Power Problem

  PER CLINICAL REVIEW: ON (B)(6) 2025, THE TEAM AT THE USER FACILITY EXPERIENCED A PROBLEM WITH THE HEART LUNG MACHINE DURING CARDIOPULMONARY BYPASS WHEREBY THE CENTRIFUGAL CONTROL UNIT DISPLAY WAS BLINKING. THEY CONTINUED TO USE THE DEVICE TO COMPLETE THE CASE AS THE INFORMATION WAS AVAILABLE ON THE CENTRAL CONTROL MONITOR (CCM). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO BLOOD LOSS, AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096655 ↗
• MalfunctionSep 4, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CENTRIFUGAL CONTROL UNIT (CCU) DISPLAY WAS BLANK. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22973764 ↗
• MalfunctionAug 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THERE WERE MISSING PIXELS ON THE DISPLAY OF THE CENTRIFUGAL CONTROL UNIT (CCU) CAUSING IT TO BE PARTIALLY UNREADABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900492 ↗
• MalfunctionAug 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THAT SOME PIXELS ON THE CENTRIFUGAL CONTROL UNIT (CCU) LOCAL DISPLAY WERE NOT ILLUMINATING CAUSING A PORTION OF THE DISPLAY TO BE DIFFICULT TO READ. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891448 ↗
• MalfunctionAug 20, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL MOTOR STOPPED WORKING IN THE MIDDLE OF THE CASE AND THE TEAM HAD TO HAND CRANK FOR THREE MINUTES AND THEN THE HEART LUNG MACHINE (HLM) WAS SWITCHED OUT FOR ANOTHER MACHINE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854048 ↗
• MalfunctionAug 6, 2025Output Problem; Output Problem

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THE CENTRIFUGAL PUMP HAD AN 'OVERSPEED' MESSAGE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727887 ↗
• MalfunctionJun 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL CONTROL UNIT (CCU) DISPLAY WAS MISSING PIXELS, AND THE LETTERS WERE ILLEGIBLE AND UNABLE TO BE READ. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22251374 ↗
• MalfunctionMay 22, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL MOTOR SHUT OFF. AS MITIGATION, THE USER USED A MANUAL CENTRIFUGAL HAND CRANK TO FINISH THE LAST FIVE MINUTES OF THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072403 ↗
• MalfunctionMar 4, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL CONTROL UNIT (CCU) BLANKED OUT FOR A BRIEF MOMENT BEFORE COMING BACK ON. THE INFORMATION WAS STILL PRESENT ON THE CENTRAL CONTROL MONITOR (CCM) AND THE ISSUE DID NOT REOCCUR. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518513 ↗
• MalfunctionFeb 6, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL MOTOR HAD INCONSISTENT FLOW, DECREASING AND GOING BACK TO NORMAL, THEN DECREASING AGAIN. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21328957 ↗
• MalfunctionOct 29, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL CONTROL UNIT (CCU) HAD NO FORWARD FLOW. THE TEAM OPEN AND CLOSED THE FLOW SENSOR AND THE ISSUE REMAINED. THE CENTRIFUGAL HEAD WAS CHECKED AND FOUND TO BE SEATED PROPERLY WITHIN THE DRIVE MOTOR. THE CLINICIAN STARTED TO HAND CRANK WHEN THE TEAM PLACED THE CENTRIFUGAL HEAD BACK INTO THE DRIVE MOTOR AGAIN AND THE ISSUE WAS RESOLVED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20562006 ↗
• MalfunctionSep 27, 2024Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL CONTROL UNIT (CCU) HEAD TURNED OFF AND ON WITH NO ERROR MESSAGE DISPLAYED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SLIGHT DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321420 ↗
• MalfunctionSep 10, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL CONTROL UNIT (CCU) DISPLAY BLANKED OUT INTERMITTENTLY. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186025 ↗
• MalfunctionSep 6, 2024Improper Flow or Infusion; Improper Flow or Infusion

  PER CLINICAL REVIEW: ON (B)(6) 2024, THE TEAM AT THE USER FACILITY EXPERIENCED A PROBLEM WITH THEIR CENTRIFUGAL CONTROL UNIT DURING AN ADULT CARDIOPULMONARY BYPASS PROCEDURE WHEREBY THE UNIT COULD NOT PRODUCE FORWARD FLOW DESPITE SHOWING 3000 REVOLUTIONS PER MINUTE (RPMS) ON THE MONITOR. NO HIGH PRESSURE OR RETROGRADE FLOW ALARMS WENT OFF ON THE PUMP, SO THE TEAM WAS NOT SURE WHAT HAPPENED. IT WAS THOUGHT TO HAVE POSSIBLY BEEN A HIGH PRESSURE EXCURSION EVENT WITH THE PATIENT. THE TEAM OPTED TO COME OFF BYPASS AND AFTER 10 MINUTES, THEY TRIED AGAIN ON THE SAME CIRCUIT, AND IT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157116 ↗
• MalfunctionApr 19, 2024Power Problem; Power Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL CONTROL UNIT (CCU) WOULD NOT TURN ON. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144001 ↗
• MalfunctionApr 19, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL CONTROL UNIT (CCU) HAD AN ISSUE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143706 ↗
• MalfunctionDec 18, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL CONTROL UNIT (CCU) DISPLAYED AN 'ARTERIAL SERVICE PUMP' MESSAGE. AS MITIGATION, THE TEAM USED A ROLLER PUMP IN PLACE OF THE CENTRIFUGAL. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347291 ↗
• MalfunctionAug 29, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL CONTROL UNIT (CCU) SCREEN FROZE AND WAS MISSING PIXELS. THE SCREEN WAS STILL READABLE AND THE CCU WAS ABLE TO BE CONTROLLED BY THE CENTRAL CONTROL MONITOR (CCM) FOR THE REMAINDER OF THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646800 ↗