Terumo® Advanced Perfusion System 1 816570Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00886799001363), received between Jun 12, 2019 and Sep 21, 2026 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (26 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Inadequate User Interface

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840542 ↗
• MalfunctionSep 17, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808578 ↗
• MalfunctionDec 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CARDIOPLEGIA PUMP DISPLAY ABRUPTLY TURNED OFF THEN CAME BACK ON. 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 23844324 ↗
• MalfunctionDec 17, 2025Mechanical Jam; Output Problem; Mechanical Jam; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP STAYED AT ONE REVOLUTION PER MINUTE (RPM), THEN STOPPED, AND THEN JAMMED. 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 23828524 ↗
• MalfunctionNov 25, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP PRESSURE WAS UNABLE TO BE SET. 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 23652936 ↗
• MalfunctionNov 24, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CARDIOPLEGIA PUMP TOOK LONGER THAN THE OTHER PUMPS TO GET TO THE RIGHT PRESSURE AND THE PRESSURE DROPPED AND WAS NOT MAINTAINING. 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 23638322 ↗
• MalfunctionNov 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE ROLLER PUMP DISPLAY WAS FOUND PIXELATED AND THERE WAS A PRESENCE OF MULTIPLE LINES ON THE DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526113 ↗
• MalfunctionNov 7, 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 ROLLER PUMP SCREEN WAS COMPLETELY BLACK BUT COULD STILL BE CONTROLLED BY THE CENTRAL CONTROL MONITOR (CCM). HOWEVER, THE SCREEN 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 23497206 ↗
• MalfunctionNov 3, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ROLLER PUMP JAMMED AND WOULD NOT HOLD AN OCCLUSION. 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 23458627 ↗
• MalfunctionOct 30, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, ROLLER PUMP TUBING WAS GETTING PULLED THROUGH THE RACEWAY AND BUNCHING UP ON THE OUTSIDE. 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 23430879 ↗
• MalfunctionOct 15, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ROLLER PUMP DISPLAY WENT BLANK. AS MITIGATION, THE TEAM USED THE CONTROLS ON THE CENTRAL CONTROL MONITOR (CCM). THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23283279 ↗
• MalfunctionAug 27, 2025Output Problem; Output Problem

  DURING FIELD INSTALLATION OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT WHEN THE ROLLER PUMP ENCODER WHEEL WAS TURNED SLIGHTLY TO TURN THE PUMP ON, IT WOULD QUICKLY SPIN AND THEN STOP AND DISPLAYED A 'PUMP JAM' MESSAGE. THE FSR THEN REMOVED THE PUMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906797 ↗
• MalfunctionAug 20, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CARDIOPLEGIA (CPG) ROLLER PUMP ENCODER KNOB WAS NOT FUNCTIONING PROPERLY, AS SLIGHTLY TURNING WOULD CAUSE THE SPEED TO JUMP MUCH QUICKER THAN USUAL. 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 22853899 ↗
• MalfunctionAug 19, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CARDIOPLEGIA PUMP DISPLAYED AN 'OVERCURRENT' MESSAGE. 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 22846181 ↗
• MalfunctionJun 27, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CARDIOPLEGIA ROLLER PUMP DISPLAYED A 'PUMP ERROR' MESSAGE. AS MITIGATION, THE PERFUSIONIST POWER CYCLED THE ROLLER PUMP 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 22349900 ↗
• MalfunctionJun 27, 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 ROLLER PUMP HAD A BLANK SCREEN. AS MITIGATION, THE ROLLER PUMP WAS CONTROLLED VIA THE CENTRAL CONTROL MONITOR (CCM). 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 22349863 ↗
• MalfunctionMay 29, 2025Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP HAD A RETAINING RING THAT CAME LOOSE WHICH PREVENTED THE OCCLUSION FROM BEING ABLE TO BE SET CORRECTLY. 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 22105191 ↗
• MalfunctionMay 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP WENT BLANK. THE TEAM UNPLUGGED THE PUMP AND PLUGGED IT BACK IN AND THE ISSUE REMAINED. THE PUMP WAS REMOVED FROM THE BASE, AND WHEN IT WAS PUT BACK ON, THE ISSUE WAS RESOLVED. THE PUMP WAS USED FOR THE REMAINDER OF THE CASE WITH NO ISSUES. 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 22074144 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP MAGNET FROM THE INSIDE OF THE LID WAS BROKEN, CAUSING THE SENSOR TO CONSTANTLY READ THAT THE LID WAS OPEN. 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 21860829 ↗
• MalfunctionApr 1, 2025Mechanical Problem; Mechanical Problem

  ROLLER PUMP WILL NOT SPIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748007 ↗
• MalfunctionMar 4, 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 ROLLER PUMP DISPLAY WAS INTERMITTENTLY BLANK. THE SYSTEM WAS REBOOTED, AND THE ISSUE 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 21518308 ↗
• MalfunctionFeb 20, 2025Mechanical Problem; Mechanical Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE ROLLER PUMP QUICKLY SKIPPED OR PAUSED BUT KEPT NORMAL ROTATIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424063 ↗
• MalfunctionDec 9, 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, A ROLLER PUMP DISPLAY WENT BLANK. 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 20882744 ↗
• MalfunctionNov 26, 2024Mechanical Problem; Mechanical Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE ROLLER PUMP BELT WAS SLIPPING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788779 ↗
• MalfunctionSep 30, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE ROLLER PUMP SCREEN WAS DAMAGED WITH A RIP IN IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339787 ↗