Cardiovascular Procedure Kit 76320Recalls & 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 00699753508460), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection1
Patient problems
- Blood Loss1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2019Disconnection; Disconnection
THE CUSTOMER REPORTED THAT WHILE ON CARDIOPULMONARY BYPASS (CPB), A CUSTOMER MADE CONNECTION OF LINE 18 TO THE R1 PORT ON THE RESERVOIR, DISCONNECTED. IT RESULTED IN APPROXIMATELY 100 MILLILITERS (ML) OF BLOOD LOSS AND A 1 MINUTE DELAY TO THE PROCEDURE. THE PRODUCT WAS NOT CHANGED OUT AND THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Blood Loss; No Known Impact Or Consequence To Patient
MAUDE report 9178887 ↗
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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