Cardiovascular Procedure Kit 74109Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699753482616), received between Jun 14, 2018 and Jul 2, 2018 — classified as 2 injuries.

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

• InjuryJul 2, 2018Crack; Connection Problem; Crack; Connection Problem

  THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE OXYGENATOR OUTLET BROKE. IT RESULTED IN APPROXIMATELY 1 LITER OF BLOOD LOSS AND A BLOOD TRANSFUSION WAS REQUIRED. THE DEVICE WAS CHANGED OUT, RESULTING IN A 15 MINUTE DELAY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss

  MAUDE report 7656196 ↗
• InjuryJun 14, 2018Break; Crack; Leak/Splash

  A (B)(6) MALE UNDERWENT TRIPLE CORONARY ARTERY BYPASS. THE PT'S CHEST WAS OPEN, THE CARDIOPLEGIC SOLUTION WAS APPLIED TO STOP THE HEART, THE CROSS-CLAMP WAS APPLIED, AND THE PT WAS ATTACHED TO THE CARDIOVASCULAR TUBING ON THE HEART-LUNG MACHINE, WHEN A LOW LEVEL PUMP ALARM ALERTED THE PERFUSIONIST THAT BLOOD WAS BELOW THE PRE-SET LEVEL OF 300 MLS IN THE RESERVOIR. A LEAK AT THE OUTLET PORT ON THE OXYGENATOR WAS IDENTIFIED, AND THE OUTLET PORT WAS IDENTIFIED AS BEING COMPLETELY BROKEN OFF, AND THE NOW SHORTENED OUTLET PORT WAS TOO SHORT TO BE ABLE TO RE-CONNECT TUBING TO IT. ATTEMPTS WERE MADE TO INITIALLY SEAL THE CRACK, BUT DID NOT WORK. THE SURGEON HAND MASSAGED THE HEART WHILE THE PERFUSIONIST EXCHANGED OUT THE BROKEN TERUMO FX 25 OXYGENATOR WITH A NEW ONE. AN EMERGENT BLOOD TRANSFUSION OF 4 UNITS PRBC'S AND 1 UNIT PLATELETS WAS QUICKLY ADMINISTERED THROUGH A CENTRAL LINE WHILE THE OXYGENATOR WAS BEING REPLACED. THE HEART-LUNG MACHINE WAS ANALYZED BY THE VENDOR FOR LIVANOVA, AND DEEMED TO BE WORKING FINE SEVERAL DAYS LATER. A COMPLAINT WAS FILED WITH TERUMO, THE MFR OF THE CARDIOVASCULAR PROCEDURE KIT, AND PUT ON NOTICE REGARDING LOT # WC 26, AND THE FX 25 OXYGENATOR (SERIAL NUM

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7605226 ↗