Cardiovascular Procedure Kit 75295-01Recalls & reported problems
Terumo Cardiovascular Systems Corporation
All models of Cardiovascular Procedure Kit (227)
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 00699753501508), received between Nov 21, 2021 and Nov 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Incomplete or Inadequate Connection1
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.
MalfunctionNov 21, 2021Crack; Incomplete or Inadequate Connection; Crack; Incomplete or Inadequate Connection
THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THERE WAS A SUSPECTED POSSIBLE MOLDING/CASTING DEFECT THAT RESULTED IN A LEAK.. A HAIRLINE FRACTURE WAS OBSERVED IN FEMALE LUER COMPONENT OF 3/8" X 3/8" LUERED CONNECTOR, LOCATED BETWEEN PUMP AND INLET TO THE OXYGENATOR OF CPB CIRCUIT. BONE WAX WAS APPLIED IN ORDER TO STOP THE LEAK AND GET THROUGH THE REMAINDER OF THE CASE. IT RESULTED IN APPROXIMATELY 100ML OF BLOOD LOSS, AND NO DELAY WAS REPORTED. THE PRODUCT WAS NOT CHANGED OUT, SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12849943 ↗
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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