Cardiovascular Procedure Kit 76168Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699753505469), received between Jun 8, 2018 and Jun 28, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 28, 2018Disconnection; Connection Problem; Disconnection; Connection Problem

  THE CUSTOMER REPORTED THAT DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TUBING ON LINE 13 DISCONNECTED FROM THE 1/4'' CONNECTOR PORT ON LINE 3. THIS DISCONNECT OF A USER MADE CONNECTION RESULTED IN A 200 CC BLOOD LOSS. THE LINE WAS RECONNECTED AND NOT CHANGED OUT. THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 7645385 ↗
• MalfunctionJun 8, 2018Disconnection; Connection Problem; Disconnection; Connection Problem

  THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE TUBING ON LINE 6 DISCONNECTED FROM THE OPEN 3/8'' CONNECTOR PORT ON LINE 7 (A USER-MADE CONNECTION) RESULTING IN 200CC BLOOD LOSS. THERE WAS A 1 TO 2 MINUTES OF DELAY WHILE THE LINE WAS RECONNECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 7582047 ↗