Cardiovascular Procedure Kit 75911Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753501850), received between Dec 23, 2020 and Dec 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionDec 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED AT THE END OF A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, WHILE TRANSFERRING THE CARDIOPLEGIA MIXTURE OF BLOOD AND CRYSTALLOID TO THE CELL SAVER THE TEMP WELL WAS DISLODGED AND FELL OUT OF THE CONNECTOR LUER PORT. THIS RESULTED IN AN APPROXIMATE 30 MILLILITERS (ML) LOSS OF MIXED CARDIOPLEGIA CONSISTING OF BLOOD AND CRYSTALLOID. THE PRODUCT WAS NOT CHANGED OUT. THE LINE WAS CLAMPED AND THE TRANSFER STOPPED. ADDITIONALLY, NO CARDIOPLEGIA WAS BEING ADMINISTERED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY NOR ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 11066698 ↗