Titan Flex 360 Stabilizer T401232URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699753450851), received between Nov 9, 2021 and Feb 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2023Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE VACUUM TUBING BROKE. AS PER USER FACILITY, DURING THE USE OF THE STABILIZER, THE VACUUM TUBING FREQUENTLY CAME OFF AND THE PROCEDURE COULD NOT BE PERFORMED, THEREFORE THEY REPLACED IT WITH A BACKUP TO CONTINUE THE PROCEDURE. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396913 ↗
• MalfunctionNov 9, 2021Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE DEVICE WAS UNABLE TO VACUUM. AS PER CLINICAL SPECIALIST A SURGEON WAS USING A TITAN FLEX 360 STABILIZER AND NOTED THAT THE VACUUM WAS WEAK AND WOULD NOT HOLD THE TISSUE WELL, DESPITE INCREASING THE VACUUM TO -600 MMHG. IT IS UNKNOWN IF ANY SIGNIFICANT PROCEDURAL DELAY WAS CAUSED BY THIS PROBLEM. TERUMO CONTINUES AN ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777929 ↗