Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. 3CX*FX25RWRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00699753450479), received between Feb 11, 2019 and May 19, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2021Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS NOT ABLE TO TRANSFER AN EFFICIENT AMOUNT OF GAS. AT ONE POINT, THERE WAS AN INCREASE OF ~730 RPMS TO MAINTAIN THE SAME 5.6 LPM BLOOD FLOW RATE. THE PCO2 VALUES STARTED TO INCREASE AND THE PO2 VALUES STARTED TO DECREASE RESULTING IN THE NEED FOR 100% FIO2 AND 15 LPM GAS FLOW. THE ACT VALUES KEPT DECREASING DESPITE NUMEROUS ADDITIONAL DOSES OF HEPARIN BEING ADMINISTERED DURING CPB. THE ACT VALUES RESPONDED TO THE HEPARIN ADMINISTRATION INITIALLY BUT THEN BEGAN TO DETERIORATE. THE ACT VALUES DECREASED TO 439, 474 AND 457 DURING CPB. NO HEALTH CONSEQUENCES OR IMPACT TO PATIENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847914 ↗
• MalfunctionMar 5, 2021Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY HAD TO RUN SWEEP AT 10 FOR ALMOST THE WHOLE CASE AND THE PC02 WENT UP TO 60. THE PATIENT WAS SEVERELY METABOLICALLY ACIDOTIC PRIOR TO BEING PLACED ON CPB. THE PATIENT WAS GIVEN 300 MEQ SODIUM BICARBONATE DURING CPB. THE LAST DOSE OF NAHCO3 WAS GIVEN AT 2049, THE SWEEP GAS WAS INCREASED FROM 7 LPM AT 2041 TO 10 LPM AT 2112 THEN THE SWEEP GAS WAS DECREASED TO 5 LPM AT 2140. TOTAL CPB TIME WAS 1800 TO 2211. NO HEALTH CONSEQUENCES OR IMPACT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423313 ↗
• MalfunctionAug 4, 2020Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A DEFECT WITH TEMPERATURE PROBE. IT IS STILL UNKNOWN WHEN THE EVENT OCCURRED, IF IT RESULTED IN A DELAY IN THE PROCEDURE NOR IF IT CAUSED OR CONTRIBUTED TO AN INJURY TO THE PATIENT OR IF THERE WAS A BLOOD LOSS. TERUMO CONTINUES AN ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 10364344 ↗
• MalfunctionMar 10, 2020Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, AIR WAS BUBBLING UP THROUGH AND DE-PRIMING THE VENOUS STRAW WHEN THE PUMP WAS OFF AND THE VENOUS LINE CLAMPED. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 9813914 ↗
• MalfunctionNov 8, 2019No Flow; No Flow

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, NO BLOOD FLOW COULD BE ESTABLISHED THROUGH SAMPLING LINE AT THE BLOOD OUTLET PORT OF THE OXYGENATOR. BLOOD SAMPLES WERE TAKEN AT THE THREE-WAY-VALVE ON THE ARTERIAL FILTER. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9298542 ↗
• MalfunctionSep 17, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, IT WAS NOTED THAT THERE ARE TEARS IN THE STERILE PACKAGE OF THE OXYGENATOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9078748 ↗
• MalfunctionSep 16, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THERE WERE TEARS IN THE STERILE PACKAGE OF THE OXYGENATOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9071803 ↗
• MalfunctionMay 20, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL PROBE WAS NOT READING TEMPERATURE.   NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8625648 ↗
• MalfunctionFeb 11, 2019Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OTHER NON-CLINICAL ACTIVITY, THE CAPS OF THE VENOUS RESERVOIR OUTLET FELL OFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8327404 ↗
• MalfunctionFeb 11, 2019Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING NON CLINICAL ACTIVITY, THE CAPS OF THE VENOUS RESERVOIR OUTLET FELL OFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8327390 ↗