Cardiovascular Procedure Kit 76415Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753507227), received between Sep 27, 2018 and Sep 27, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Connection Problem” (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.

• InjurySep 27, 2018Disconnection; Connection Problem; Disconnection; Connection Problem

  IT WAS REPORTED THAT DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE 3/8 INCHES TUBING ATTACHED TO THE OUTLET PORT ON THE FX25 BEING USED GOT DISCONNECTED. THE CUSTOMER MADE THE CONNECTION BY PLACING THE TUBING OVER THE 2ND BARB OF THE OXYGENATOR OUTLET PORT. WHILE ON BYPASS THE LINE DISCONNECTED RESULTING IN APPROXIMATELY A 500 ML BLOOD LOSS. THE PRODUCT WAS NOT CHANGED OUT SINCE THE PERFUSIONIST WAS ABLE TO SAFELY RECONNECT THE LINE. THERE WAS NO TRANSFUSION REQUIRED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CUSTOMER CONFIRMED THAT PATIENT WAS OKAY.

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

  MAUDE report 7915756 ↗