Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. 3CX*FX25RERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00699753450462), received between Feb 8, 2019 and Jul 15, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE BLOOD WAS DRIPPING OUT OF THE FIBRE BUNDLE AND OUTLET PORT. AT APPROXIMATELY 30 MINUTES AFTER STARTING CARDIOPULMONARY BYPASS, BLOOD WAS NOTED TO BE DRIPPING FROM THE PORT/OPENING BELOW THE BLOOD INLET. THEY WERE UNSURE WHERE THE BLOOD WAS COMING FROM, THEREFORE, THEY PLACED SOME BONE WAX ALONG SOME SEAMS TO LOOK FOR CHANGES. THERE WAS NO CHANGE IN THE BLOOD DRIP RATE, AND DID NOT SEEM TO BE ANY FAILURE OF THE OXYGENATOR. THERE WAS NO HARM TO PATIENT; HENCE, THE OXYGENATOR WAS NOT CHANGED OUT AND A CLOSE MONITORING WAS DONE FOR OXYGENATOR FAILURE AND INCREASE BLEEDING. THERE WAS A BLOOD LOSS OF LESS THAN 100 MLS. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177067 ↗
• MalfunctionMar 8, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS PROCEDURE THERE WAS AN ISSUE WITH THE OXYGENATOR. THERE WAS A CLEAR SPOT AT TOP THE OXYGENATOR OVER THE CENTER OF THE FIBER BUNDLE, OUTSIDE OF THE FILTER MATERIAL. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405713 ↗
• MalfunctionFeb 8, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THAT THERE WAS A LEAK IN THE MANIFOLD LINE NEAR THE 1-WAY VALVE. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP. THERE WAS A 5 MINUTE DELAY . PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8320315 ↗