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Titan Flex Stabilizer T401232Recalls & reported problems

Terumo Cardiovascular Systems Corporation · Class 1

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 00699753450844), received between Aug 31, 2022 and Aug 31, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Output below Specifications” (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

Device problems

  • Output below Specifications1

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.

  • MalfunctionAug 31, 2022Output below Specifications; Output below Specifications

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, AFTER CARDIOPULMONARY BYPASS, THE ARTERIAL / VENOUS TEMPERATURE WERE 4 DEGREES BELOW. PER FACILITY, PERFUSIONIST WAS REWARMING THE ARTERIAL /VEN TEMPS WERE 4 DEGREES BELOW WATER BATH AND BLADDER TEMP PROBE. THEY HAVE DONE AN EQUIPMENT CHECK AND FEEL THE TEMP PROBES AND OR OXY TEMP WELLS MAY HAVE AN ISSUE. CDI550 CORRESPONDED WITH OXY ART/VEN. THEY CHANGED OUT PROBES WITH NEW ONES TO RESOLVE THE PROBLEM. NO PATIENT IMPACT OR INVOLVEMENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15331414 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.