Titan Stabilizer Attachment 45055Recalls & reported problems
Terumo Cardiovascular Systems Corporation
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699753450554), received between Aug 20, 2019 and Feb 6, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
- Use of Device Problem1
Patient problems
- Blood Loss1
- No Known Impact Or Consequence To Patient1
- Tissue Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2020Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, WHILE USING THE TITAN STABILIZER, THE RIGHT METAL WISHBONE PART OF THE FOOTPLATE RUBBED A HOLE IN THE HEART. A HEMOSTATIC AGENT WAS USED TO STOP THE BLEEDING. THERE WAS APPROXIMATELY 100 ML OF BLOOD LOSS, THERE WAS MINIMAL DELAY, THE PRODUCT WAS NOT CHANGED OUT, THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Blood Loss; Tissue Damage
MAUDE report 9679645 ↗MalfunctionAug 20, 2019Fracture; Fracture
ADDITIONAL INFORMATION RECEIVED THAT NO BLOOD LOSS DURING THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8910584 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page