Terumo® Advanced Perfusion System 1 803480Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00886799000779), received between Mar 19, 2019 and Mar 19, 2026 — classified as 14 malfunctions.

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

• MalfunctionMar 19, 2026Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE OCCLUDER MODULE WAS NOT OPERATING AND A QUESTION MARK (?) WAS DISPLAYED ON THE SCREEN OVER THE OCCLUDER ICON. THE MODULE WAS FULLY INSERTED INTO THE BASE, BUT NO STATUS INDICATION WAS PRESENT ON THE MODULE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642640 ↗
• MalfunctionAug 5, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A '?' OVER THE OCCLUDER MODULE ICON. THE PERFUSIONIST REMOVED THE MODULE, RESEATED IT AND THE ISSUE RESOLVED. 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 19908042 ↗
• MalfunctionOct 6, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THERE WAS AN OCCLUDER ERROR. AFTER A WHILE, THE ERROR RESOLVED ON ITS OWN AND THE OCCLUDER WAS USED 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 17886711 ↗
• MalfunctionAug 17, 2023Output Problem; Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE USER FACILITY RECALIBRATED THE OCCLUDER AND THE ISSUE WAS RESOLVED. PER CLINICAL REVIEW: THE USER REPORTED AN ISSUE WITH THEIR HEART LUNG MACHINE (HLM) DURING CARDIOPULMONARY BYPASS (CPB). SPECIFICALLY, WHEN INITIATING CPB THE VENOUS OCCLUDER WENT TO FULL OCCLUSION WITHOUT INPUT FROM THE USER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS TO THE PROCEDURE AND NO BLOOD LOSS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568289 ↗
• MalfunctionJun 28, 2023Output Problem; Output Problem

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT THE VENOUS OCCLUDER WENT TO CLOSED AND INTO CALIBRATION MODE ON ITS OWN. AS MITIGATION, THE USER MANUALLY OPENED THE VENOUS OCCLUDER CLAMP AND THE SURGERY WAS COMPLETED WITHOUT ISSUE. 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 17216121 ↗
• MalfunctionJan 3, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE OCCLUDER WAS ACTING DIFFERENTLY THAN EXPECTED AND DISPLAYED A CALIBRATE ('CAL') MESSAGE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE USER FACILITY REPORTED AN ISSUE WITH THE HEART LUNG MACHINE (HLM) DURING CPB. THEY STATED THAT THE OCCLUDER WAS ACTING DIFFERENT BUT DID NOT SPECIFICALLY STATE HOW. NEXT, THE 'CAL' MESSAGE APPEARED ON THE OCCLUDER ICON. THIS EVIDENTLY OCCURRED WHILE ON CPB, BUT AFTER THEY DID CALIBRATION DURING SET-UP. THIS SITUATION DID NOT RESULT IN A DELAY TO THE CASE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO INJURY/BLOOD LOSS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088235 ↗
• MalfunctionFeb 14, 2020Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE ISSUE OCCURRED DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9712593 ↗
• MalfunctionFeb 14, 2020Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE ISSUE HAPPENED DURING SETUP. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9712582 ↗
• MalfunctionFeb 14, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE OCCLUDER WAS NOT CALIBRATING. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9712511 ↗
• MalfunctionFeb 14, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER HEAD DISPLAYED A 'VENOUS OCCLUSION NEEDS TO BE RECALIBRATED' MESSAGE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE VENOUS OCCLUDER WAS CALIBRATED AND USED DURING A CPB PROCEDURE ON (B)(6) 2020. TOWARDS THE END OF THE PROCEDURE THE USER WAS GIVEN A VENOUS OCCLUSION RECALIBRATION MESSAGE, AND THE DEVICE TOTALLY OCCLUDED THE VENOUS LINE FROM THE PATIENT. THE PERFUSIONIST STATED THAT SHE LOST ALL OF HER DRAINAGE, BUT SHE WAS ABLE TO OPEN THE VENOUS OCCLUDER AND USE MANUAL CLAMPS FOR THE REMAINDER OF THE PROCEDURE. THIS ISSUE DID NOT DELAY THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO HARM OR BLOOD LOSS ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712380 ↗
• MalfunctionJan 27, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE RED LIGHT EMITTING DIODE (LED) OF THE OCCLUDER MODULE WAS BURNT OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9635244 ↗
• MalfunctionNov 27, 2019Calibration Problem; Calibration Problem

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT THE OCCLUSION ON THE OCCLUDER WAS RELEASED AND CALIBRATION ERROR OCCURRED INTERMITTENTLY. THERE WERE NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9382862 ↗
• MalfunctionMar 21, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE OCCLUDER MODULE WAS CAUSING AN ERROR MESSAGE TO CHECK MODULE TO BE DISPLAYED.THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8441124 ↗
• MalfunctionMar 19, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OCCLUDER MODULE WAS CAUSING AN ERROR MESSAGE TO CHECK MODULE TO BE DISPLAYED. THE HEART LUNG MACHINE (HLM) WAS USED WITHOUT THE OCCLUDER. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8431821 ↗