Cardiovascular Procedure Kit 75564-01Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00699753516069), received between Oct 28, 2025 and Oct 31, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Crack3
- Leak/Splash3
- Pressure Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Crack; Leak/Splash; Pressure Problem; Crack; Leak/Splash; Pressure Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE MALE CONNECTOR ON LINE 11 LEAKED DUE TO A CRACK IN THE CONNECTOR AND COULD NOT PROVIDE ENOUGH PRESSURE TO UTILIZE THE CARDIOPLEGIA LINE. AS MITIGATION, THE TEAM REPLACED THE LINE WITH AN EIGHT-FOOT PRESSURE LINE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437402 ↗MalfunctionOct 31, 2025Crack; Leak/Splash; Pressure Problem; Crack; Leak/Splash; Pressure Problem
PER CLINICAL REVIEW: THIS COMPLAINT INVOLVED A TUBING PACK THAT HAD A MALE CONNECTOR IN ONE OF THE ANCILLARY TUBING LINES LEAK BLOOD DURING CARDIOPULMONARY BYPASS. THE LINE AND CONNECTOR WERE CHANGED OUT WITH ANOTHER LINE/CONNECTOR AND THERE WAS NO HARM TO THE PATIENT. THE LINE AND CONNECTOR WERE NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND NO PICTURES WERE TAKEN BY THE CUSTOMER AND SHARED. THIS COMPLAINT IS MOST LIKELY A WORKMANSHIP ISSUE WITH NOT ENOUGH SOLVENT BOND APPLICATION TO THE LINE AND CONNECTOR, BUT WITHOUT THE RETURN OF THE COMPLAINT DISPOSABLE, IT IS DIFFICULT TO GIVE A DEFINITIVE ROOT CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437356 ↗MalfunctionOct 28, 2025Crack; Leak/Splash; Pressure Problem; Crack; Leak/Splash; Pressure Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE MALE CONNECTOR ON LINE 11 LEAKED DUE TO A CRACK IN THE CONNECTOR AND COULD NOT PROVIDE ENOUGH PRESSURE TO UTILIZE THE CARDIOPLEGIA LINE. AS MITIGATION, THE TEAM REPLACED THE LINE WITH AN EIGHT-FOOT PRESSURE LINE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410390 ↗
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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