Cardiovascular Procedure Kit 75106-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753504677), received between Jan 25, 2019 and Jan 25, 2019 — classified as 1 injury.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT DURING THE CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TUBING CONNECTOR FROM THE TERUMO CARDIOVASCULAR PROCEDURE KIT AND THE TUBING FROM ANOTHER MANUFACTURER'S KIT DISCONNECTED, RESULTING IN APPROXIMATELY 2000-2200 ML BLOOD LOSS. THIS WAS A USER MADE CONNECTION THAT HAD NOT BEEN TIE BANDED. THERE WAS A DELAY OF APPROXIMATELY 3 MINUTES WHILE THE CONNECTOR AND TUBING WERE RECONNECTED. THE USER INDICATED THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE SURGERY WAS SUCCESSFULLY COMPLETED. IT WAS ALSO REPORTED THAT THERE NO SERIOUS ADVERSE PATIENT IMPACT OR POST-SURGICAL COMPLICATIONS.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 8278861 ↗