Terumo® Advanced Perfusion System 1 890500Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00886799001813), received between Apr 8, 2024 and Aug 28, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Output Problem” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499058 ↗
• MalfunctionMar 30, 2026Inadequate User Interface

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) TOUCHSCREEN HAD AN ISSUE WHEN ATTEMPTING TO ADJUST THE SLIDER FOR THE OCCLUDER. 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 24729788 ↗
• MalfunctionDec 12, 2025Output Problem; Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISSUE WAS INTERMITTENT, OCCURRING FIRST DURING SET-UP THEN MULTIPLE TIMES DURING TROUBLESHOOTING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 23790531 ↗
• MalfunctionOct 28, 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 CENTRAL CONTROL MONITOR (CCM) DISPLAY WOULD NOT POWER 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 23409183 ↗
• MalfunctionAug 5, 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 CENTRAL CONTROL MONITOR (CCM) WENT BLANK AND WAS NOT WORKING. 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 22723656 ↗
• MalfunctionJul 24, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'SYSTEM COMPUTER NEEDS SERVICE' 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 22592222 ↗
• MalfunctionJul 16, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'SYSTEM COMPUTER NEEDS SERVICE' MESSAGE. 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 22521836 ↗
• MalfunctionMay 29, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'SYSTEM COMPUTER NEEDS SERVICE' MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107642 ↗
• MalfunctionMay 1, 2025Power Problem; Power Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRAL CONTROL MONITOR (CCM) WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946622 ↗
• MalfunctionDec 3, 2024Inadequate User Interface; Inadequate User Interface

  ADDITIONAL INFORMATION WAS RECEIVED THAT AS A RESULT OF THE REPORTED ISSUE, 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836843 ↗
• MalfunctionOct 28, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'SYSTEM COMPUTER NEEDS SERVICE' MESSAGE MULTIPLE TIMES. 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 20549099 ↗
• MalfunctionSep 18, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) WAS BLANK UPON BOOT UP. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20251516 ↗
• MalfunctionJun 14, 2024Crack; Inadequate User Interface; Crack; Inadequate User Interface

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) WAS FOUND TO BE CRACKED WHICH CAUSED THE CURSOR SELECTIONS TO BE INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537114 ↗
• MalfunctionApr 8, 2024Inadequate User Interface; Inadequate User Interface

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) TOUCHSCREEN WAS OUT OF CALIBRATION. THE USER FACILITY ATTEMPTED A RECALIBRATION AND THE ARROW ON THE DISPLAY WENT MISSING CAUSING THE CCM TO BE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067640 ↗