Cardiovascular Procedure Kit 73990-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699753484184), received between Jun 11, 2018 and Jun 10, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, BLOOD LEAKED ACROSS THE HYDROPHOBIC MEMBRANE PORTION OF THE FILTER ON TWO OCCASIONS. IT RESULTED TO A SMALL AMOUNT OF BLOOD PASSING THROUGH THE HYDROPHOBIC MEMBRANE OF THE FILTER. THE PURGE PORT WAS CLOSED AND THERE WAS NO BLOOD LOSS EXTERNAL TO THE FILTER HOUSING. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS NO DELAY, AND THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 10140715 ↗
• MalfunctionJun 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING PRIME, THE LG LEUCOCYTE REDUCTION ARTERIAL BLOOD FILTER, LEAKED PRIMING SOLUTION ACROSS THE HYDROPHOBIC PORTION OF THE FILTER. THE PRODUCT WAS CHANGED OUT. THERE WAS NO DELAY TO THE PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONALLY THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7588086 ↗