Cardiovascular Procedure Kit 74074-02Recalls & 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753499300), received between Feb 13, 2019 and Feb 13, 2019 — classified as 1 death.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- Blood Loss1
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
DURING A RECENT CPB SURGERY THE PATIENT EXPIRED. IT WAS REPORTED BY THE PERFUSIONIST THAT THERE WAS A LEAK FROM A Y CONNECTION DURING CARDIOPULMONARY BYPASS. THE CARDIOPLEGIA LEAK AND SUBSEQUENT CHANGE OUT DID NOT CONTRIBUTE TO THE PATIENT¿S DEATH AS IT WAS NOT REQUIRED AT THE TIME OF THE CIRCUIT CHANGE OUT; THE CARDIOPLEGIA CIRCUIT CHANGE OUT DID NOT CAUSE A DELAY IN THE TREATMENT OF THE PATIENT. A (B)(6) MAN CAME TO THE EMERGENCY ROOM COMPLAINING OF CHEST PAIN. HE WAS TRANSFERRED TO THE CARDIAC CATHETERIZATION LABORATORY AND WENT INTO FULL CARDIAC ARREST. CHEST COMPRESSIONS WERE ADMINISTERED DURING TRANSPORT TO THE OPERATING ROOM FOR EMERGENT CARDIOPULMONARY BYPASS (CPB) SURGERY. PATIENT WAS EMERGENTLY PLACED ON CPB WHILE VEINS WERE BEING HARVESTED FOR THE SURGERY. THE PERFUSIONIST AT THIS TIME WAS PRIMING THE CARDIOPLEGIA CIRCUIT WITH BLOOD FROM THE CARDIOTOMY RESERVOIR AND NOTED A SMALL LEAK AT THE Y CONNECTION ~(10ML). THE PERFUSIONIST CHANGED OUT THE CIRCUIT BECAUSE THE CARDIOPLEGIA HAD NOT BEEN DELIVERED AND WAS NOT NEEDED, DURING THE VEIN HARVESTING. THERE WAS A TOTAL BLOOD LOSS OF 100-200 ML BLOOD DUE TO THE VOLUME IN THE CARDIOPLEGIA CIRCUIT.
Patient problems: Blood Loss; Death
MAUDE report 8336679 ↗
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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