Cardiovascular Procedure Kit 76923Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753509818), received between Sep 30, 2019 and Sep 30, 2019 — classified as 1 malfunction.

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

Recent adverse event reports

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

• MalfunctionSep 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, BLOOD WAS DRIPPING FROM THE CARDIOPLEGIA RECIRCULATION LINE (NUMBER13A) AT THE 1/4''X1/4'' LUER LOCK CONNECTOR. IT RESULTED IN APPROXIMATELY 50-100 MILLILITERS (ML) OF BLOOD LOSS. THE PERFUSTIONIST ATTEMPTED TO MITIGATE THE ISSUE BY REPLACING THE STOPCOCK. THIS WAS UNSUCCESSFUL. THE ISSUE WAS MITIGATED BY REPLACING THE 1/4''X1/4'' LUER LOCK CONNECTOR WITH TWO PERFUSION ADAPTERS AND A MALE/FEMALE CONNECTOR. THERE WAS NO DELAY IN THE PROCEDURE OR DELIVERY OF THE CARDIOPLEGIA SOLUTION. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 9136552 ↗