Terumo® Advanced Perfusion System 1 893607Recalls & reported problems
Terumo Cardiovascular Systems Corporation · Pressure Module Dual Sensor APS · Class 2
All models of Terumo Advanced Perfusion System 1 (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886799001844), received between May 5, 2025 and May 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Calibration Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Calibration Problem1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Unable to Obtain Readings; Calibration Problem; Unable to Obtain Readings; Calibration Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CARDIOPLEGIA (CPG) PRESSURE MODULE STOPPED WORKING AND PROMPTED FOR RECALIBRATION. 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 21963645 ↗
Other Console, Heart-Lung Machine, Cardiopulmonary Bypass devices
- Terumo® Advanced Perfusion System 1 801188Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass3 recalls447 reports
- MAQUET CARDIOHELP CARDIOHELP-iMaquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS5 recalls2 deaths64 reports
- MAQUET CARDIOHELP CARDIOHELP SystemMaquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS4 recalls18 deaths107 reports
- Terumo® Advanced Perfusion System 1 816300Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass300 reports
- Terumo® Advanced Perfusion System 1 801763Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 death230 reports
- Terumo® Advanced Perfusion System 1 816571Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass230 reports
- ESSENZ HLMLivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall1 death110 reports
- Terumo® Advanced Perfusion System 1 5773Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 recall78 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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