Terumo® Advanced Perfusion System 1 195240Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886799001704), received between Dec 2, 2019 and May 9, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (19 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 20, 2017Class IITerminated

   Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.

   Z-1458-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE HEART LUNG MACHINE (HLM) HAD A LEVEL SENSOR DISCONNECTED ALARM. 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 21995318 ↗
• MalfunctionAug 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR PAD WAS NOT STICKING TO THE RESERVOIR. AS A RESULT, 3M DOUBLE-SIDED TAPE WAS USED TO ATTACH THE LEVEL DETECTOR TO THE RESERVOIR. THE TAPE ALSO PEELED OFF AND HAD TO BE CHANGED MULTIPLE TIMES. 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 20028256 ↗
• MalfunctionAug 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR PAD WAS NOT STICKING TO THE RESERVOIR. ANOTHER LEVEL SENSOR PAD WAS USED, BUT THE ISSUE REMAINED. AS A RESULT, 3M DOUBLE-SIDED TAPE WAS USED TO ATTACH THE LEVEL DETECTOR TO THE RESERVOIR. THE TAPE ALSO PEELED OFF AND HAD TO BE CHANGED MULTIPLE TIMES. 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 20022397 ↗
• MalfunctionAug 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR PAD WAS NOT STICKING TO THE RESERVOIR. AS A RESULT, 3M DOUBLE-SIDED TAPE WAS USED TO ATTACH THE LEVEL DETECTOR TO THE RESERVOIR. THE TAPE ALSO PEELED OFF AND HAD TO BE CHANGED MULTIPLE TIMES. 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 20020080 ↗
• MalfunctionMar 23, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, MULTIPLE LEVEL SENSOR PADS DID NOT STICK TO THE OXYGENATOR PROPERLY. 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 13861867 ↗
• MalfunctionMar 23, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, MULTIPLE LEVEL SENSOR PADS DID NOT STICK TO THE OXYGENATOR PROPERLY. 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 13861773 ↗
• MalfunctionSep 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSING PAD WOULD NOT STAY ATTACHED TO THE RESERVOIR. AS A RESULT, THE PAD WAS REPLACED AND THERE WERE NO ADDITIONAL 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 12436707 ↗
• MalfunctionJul 14, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PER CLINICAL REVIEW: THE PERFUSIONIST HAD AN INCIDENT WITH THE LEVEL SENSING SYSTEM DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE ON (B)(6) 2021. SHE SET UP THE PADS, AND SENSORS PER THE INSTRUCTIONS FOR USE (IFU) FOR THE PROCEDURE. WHILE ON BYPASS, THE LEVEL SENSOR PAD ALARM KEPT GOING OFF AND THE PADS WERE FOUND TO BE PARTIALLY DETACHING. THEY WERE PUSHED BACK ON, BUT CONTINUED TO BECOME DETACHED. THE PERFUSIONIST DECIDED TO PLACE NEW PADS ON THE RESERVOIR, AND NOTED THAT THESE PADS WERE ABLE TO BE REMOVED FROM THE RESERVOIR VERY EASILY (MORE EASILY THAN EXPECTED). SHE CONFIRMED THAT SHE HAD PLACED THESE PADS ON THE RESERVOIR LONG IN ADVANCE OF PLACING THE SENSORS ONTO THE PADS (PADS WERE PLACED THE PREVIOUS EVENING). UPON REPLACING BOTH PADS WITH NEW ONES, THE PERFUSIONIST WAITED SEVERAL MINUTES BEFORE ATTACHING THE SENSORS ONTO THE PADS, BUT SUBSEQUENTLY SHE EXPERIENCED THE SAME PROBLEM, WHEREBY THE PADS WOULD NOT STAY ADHERED TO THE RESERVOIR. THE PERFUSIONIST NOTED THAT SHE HAD WIPED THE RESERVOIR SURFACE WITH ALCOHOL PRIOR TO PLACING THE SECOND SET OF PADS. THE CASE WAS COMPLETED WITHOUT INCIDENT, BUT THE PERFUSIONIST CONTINUED TO GET ALARMS DUE TO THE PADS NOT ADHERING PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167600 ↗
• MalfunctionDec 4, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR PADS WOULD NOT ADHERE TO THE RESERVOIR. AS A RESULT, LEVEL SENSOR PADS FROM ANOTHER BOX WERE USED. 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; No Consequences Or Impact To Patient

  MAUDE report 10950030 ↗
• MalfunctionAug 28, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR PADS WERE NOT STICKING TO THE VENOUS RESERVOIR AND WERE CAUSING AN ALARM. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED. PER CLINICAL REVIEW: THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE LEVEL SENSING SYSTEM INCIDENT THAT OCCURRED DURING A CPB PROCEDURE ON (B)(6) 2020. ACCORDING TO THE OBTAINED INFORMATION, THE LEVEL SENSING SYSTEM ALARMED TWO TIMES DURING A PROCEDURE, AND THE TEAM PROCEEDED TO EXCHANGE THE LEVEL SENSING PADS. IT WAS NOT KNOWN WHAT TYPE OF RESERVOIR SYSTEM THE TEAM USED. THIS 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 10464666 ↗
• MalfunctionAug 27, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR PADS WERE NOT STICKING TO THE VENOUS RESERVOIR AND CAUSING AN ALARM. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. CLINICAL REVIEW: THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE LEVEL SENSING SYSTEM INCIDENT DURING A CARDIOPULMONARY BYPASS PROCEDURE ON (B)(6) 2020. ACCORDING TO THE OBTAINED INFORMATION, THE TEAM HAD THE LEVEL SENSING SYSTEM ALARM FIVE TIMES DURING A PROCEDURE, AND THE TEAM PROCEEDED TO EXCHANGE THE LEVEL SENSING PADS. IT WAS NOT KNOWN WHAT TYPE OF RESERVOIR SYSTEM THE TEAM USED. THIS 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 10461469 ↗
• MalfunctionAug 27, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL DETECTION PADS WERE NOT STICKING TO THE RESERVOIR. AS A RESULT, AN ALTERNATIVE 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 Consequences Or Impact To Patient

  MAUDE report 10461311 ↗
• MalfunctionAug 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSING PADS WOULD NOT STICK TO THE OXYGENATOR VENOUS CARDIOTOMY RESERVOIR WALL. AS A RESULT, AN ALTERNATIVE 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 Consequences Or Impact To Patient

  MAUDE report 10375914 ↗
• MalfunctionAug 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSING PADS WOULD NOT STICK TO THE OXYGENATOR VENOUS CARDIOTOMY RESERVOIR WALL. AS A RESULT, AN ALTERNATIVE 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 Consequences Or Impact To Patient

  MAUDE report 10375889 ↗
• MalfunctionAug 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSING PADS WOULD NOT STICK TO THE OXYGENATOR VENOUS CARDIOTOMY RESERVOIR WALL. AS A RESULT, AN ALTERNATIVE 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 Consequences Or Impact To Patient

  MAUDE report 10375841 ↗
• MalfunctionAug 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSING PADS WOULD NOT STICK TO THE OXYGENATOR VENOUS CARDIOTOME RESERVOIR WALL. AS A RESULT, AN ALTERNATIVE 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 Consequences Or Impact To Patient

  MAUDE report 10375799 ↗
• MalfunctionAug 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSING PADS WOULD NOT STICK TO THE OXYGENATOR VENOUS CARDIOTOMY RESERVOIR WALL. AS A RESULT, AN ALTERNATIVE 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 Consequences Or Impact To Patient

  MAUDE report 10375795 ↗
• MalfunctionJul 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR PADS WERE NOT STICKING. 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 Consequences Or Impact To Patient

  MAUDE report 10237597 ↗
• MalfunctionJun 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR PADS WERE NOT FUNCTIONING PROPERLY. 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 10214753 ↗
• MalfunctionDec 2, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, MULTIPLE LEVEL PADS WERE NOT STICKING TO THE RESERVOIR. 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 Consequences Or Impact To Patient

  MAUDE report 9398290 ↗