Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX15RE30CRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00699753450806), received between Jun 13, 2018 and Aug 20, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50352200 ↗
• MalfunctionSep 2, 2025Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A LOT OF AIR WAS NOTICED ON THE BOTTOM OF THE RESERVOIR. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931133 ↗
• MalfunctionOct 10, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE THREADS ON THE RESERVOIR OUTLET WERE ALMOST NON-EXISTENT. AS PER THE SUBSIDIARY, THE STEP DOWN ADAPTER WAS UNABLE TO TIGHTEN ONTO THE RESERVOIR, SO THE CUSTOMER USED A PIECE OF TUBING TO SLIP ONTO THE OUTLET. THE CIRCUIT WAS ABLE TO BE USED WITH A LARGER BOOT SIZE NOT REQUIRING A STEP DOWN. THE OXYGENATOR HAS BEEN DISPOSED OF AFTER THEIR CASE, SO THERE IS NO PHOTO. NO PATIENT INVOLVEMENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423898 ↗
• MalfunctionJun 18, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING TO CARDIOPULMONARY BYPASS, THE OXYGENATOR HAD POOR GAS TRANSFER. AS PER THE USER FACILITY, THE CASE WAS FOR A CORONARY ARTERY BYPASS GRAFTING (CABG) X 5. THE FLOW THROUGHOUT THE SURGERY REMAINED AROUND 4 TO 4.5 LITERS PER MINUTE (L/MIN), WITH A SWEEP SET AT 3 LPM AND THE FRACTION OF INSPIRED OXYGEN (FIO2) WAS KEPT AT 100%. SEVOFLURANE WAS 2% THROUGHOUT THE SURGERY. THE INITIAL PARTIAL PRESSURE OF OXYGEN (PO2) UPON INITIATION WAS AT 420. ARTERIAL BLOOD GASSES (ABGS) WERE PERFORMED EVERY 30 MINUTES, WITH THE NEXT PO2 AT 159.8, FOLLOWED BY 94.8. THE RECIRCULATION LINE WAS OPENED AT THIS POINT AND SIGHING OF THE OXYGENATOR OCCURRED EVERY 10 MINUTES OR LESS. THE LAST PO2 ON PUMP BEFORE COMING OFF WAS 138.4, AND THE PATIENT'S PO2 AFTER BYPASS WAS AT 396.8. THE UNIT WAS NOT CHANGED OUT, AS THE ANESTHESIOLOGIST WAS NOTIFIED OF LOW PO2 WITH AND ALL OTHER PROTHROMBIN (PT) VALUES WERE WITHIN NORMAL RANGE. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562526 ↗
• InjuryMay 1, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED DARK BLOOD IN OXYGENATOR. *THERE WAS AN APPROXIMATELY 300-400CC OF BLOOD LOSS *PRODUCT WAS CHANGED OUT *PROCEDURE COMPLETED SUCCESSFULLY WITH UNKNOWN MINUTES OF DELAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19222549 ↗
• MalfunctionMar 14, 2024Pressure Problem; Pressure Problem

  ADDITIONAL INFORMATION RECEIVED THAT INDICATES THAT THE EVENT OCCURRED DURING CARDIOPULMONARY BYPASS, AND THE PRODUCT WAS NOT CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906863 ↗
• MalfunctionSep 27, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  DAMAGED BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830023 ↗
• MalfunctionJul 13, 2023Break; Crack; Break; Crack

  TEMPERATURE PROBE BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315886 ↗
• MalfunctionJun 22, 2023Fitting Problem; Fitting Problem

  OXYGENATOR WAS NOT PROPERLY ATTACHED TO THE RESERVIOR BRACKET WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186809 ↗
• MalfunctionJun 22, 2023Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE YELLOW CAP CAME OFF FROM THE MANIFOLD. NO PATIENT INVOLVEMENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185161 ↗
• MalfunctionJun 19, 2023Component Missing; Component Missing

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE PEDIATRIC OXYGENATOR DID NOT CONTAIN THE MOLDED TO SLIDE ONTO THE OXYGENATOR HOLDER. AS PER THE USER FACILITY, THEY TAPED THE HOLDER WITH SILK TAPE AS THE CLIP WAS MISSING. NO PATIENT INVOLVEMENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152317 ↗
• MalfunctionJan 30, 2023Output Problem; Output Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE FIO2 OF 100% AND PO2 ONLY 150. IT IS UNKNOWN WHEN THE EVENT OCCURRED, WHETHER THERE WAS DELAY IN THE PROCEDURE, WHETHER THE PRODUCT THE PRODUCT WAS CHANGED OUT, WHETHER THE SURGERY WAS COMPLETED SUCCESSFULLY, OR WHETHER THERE WAS BLOOD LOSS OR ANY EFFECT OF THE SURGERY. NO OTHER INFORMATION WAS PROVIDED BY THE ACCOUNT.

  Patient problems: Insufficient Information

  MAUDE report 16263451 ↗
• MalfunctionJan 9, 2023Output Problem; Output Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, AN FIO2 OF 100% AND THE PO2 WAS ONLY 150. NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY. ADDITIONALLY, 91 MINUTE TO PUMP RUN, WARM PATIENT; SIGHED MEMBRANE. THE ACT WAS NORMAL AND THE FLOW WAS AROUND 4.0 L/MIN BLOOD FLOW. THE PATIENT DID FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125030 ↗
• MalfunctionMay 31, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OTHER - NON CLINICAL ACTIVITY, THERE WERE EXCESS ITEMS RECEIVED WITH THEIR SHIPMENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549667 ↗
• MalfunctionNov 30, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE SUBSIDIARY RECEIVED INCORRECT OXYGENATORS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897340 ↗
• MalfunctionSep 30, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE FACILITY RECEIVED AN EASTERN CONFIGURED OXYGENATOR INSTEAD OF A WESTERN ONE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12553432 ↗
• MalfunctionOct 5, 2020Component Missing; Component Missing

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ADAPTERS WERE MISSING. NO PATIENT INVOLVEMENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 10632007 ↗
• MalfunctionSep 11, 2020Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THERE WAS A BROKEN INLET LINE ON THE ENTRANCE TO THE OXYGENATOR. ADDITIONALLY, THE PERFUSIONIST IDENTIFIED THAT THIS OCCURRED BECAUSE THE BOX CREATED PRESSURE OF THE PAPER BARRIER IN THE PACKAGE DIRECTLY ON THIS LINE. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: No Information

  MAUDE report 10521854 ↗
• MalfunctionSep 8, 2020Decrease in Pressure; Decrease in Pressure

  ADDITIONAL INFORMATION RECEIVED ABOUT THE INCIDENT THAT STATES, THE HEART-LUNG MACHINE WAS PREPARED, FILLED AND DEBUFFED AT 07.30 AM WITH CRYSTALLOID, COLLOID AND HEPARIN SOLUTIONS. THE TFPC CONNECTED THE HEAT EXCHANGER WITH THE TEMPERATURE SET AT 34 ° C DURING THE DEBOLLING PHASE AND LEFT THE CIRCUIT TO CIRCULATE UNTIL THE LINES WERE CUT FOR THE CANNULATION. THE PRE-CEC ACT WAS 452 SECONDS. THE CEC STARTED AT 01.03 PM, THE AORTA WAS CLAMPED AT 01.09 PM, MYOCARDIAL PROTECTION SAW THE ADMINISTRATION OF 1000 ML OF CUSTODIAL CARDIOPLEGIA IN 6 MINUTES THROUGH ANTEROGRADE. AT THE END OF THE CARDIOPLEGIA, CONVENTIONAL ULTRAFILTRATION BEGAN WITH A TOTAL FILTRATE OF 150 ML. SYSTEMIC FLOW MAINTAINED THROUGHOUT THE CEC WAS 3.1 L / MIN (3.0 CARDIAC INDEX) WITH A TEMPERATURE OF 32 ° C. AT THE FIRST BLOOD GAS ANALYTICAL CHECK FROM THE OXYGENATOR, DESPITE A GAS FLOW OF 3 L / MIN WITH A FIO2 OF 70%, THE PCO2 WAS 46 MMHG, THE PAO2 OF 85 MMHG AND THE ARTERIAL SATURATION OF 96%; THE CDI WAS CALIBRATED ON THE BASIS OF THESE VALUES. BASED ON A PROGRESSIVE WORSENING OF THE GAS EXCHANGE VALUES, DISPLAYED CONTINUOUSLY WITH THE CDI, THE TFPC INCREASED THE WASHES OF THE SECHRIST UP TO A FLOW OF 8 L / MIN W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10501972 ↗
• MalfunctionApr 29, 2020Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS CREATING A FROTH AND SUBSEQUENT GASES WAS DEMONSTRATING POOR OXYGENATION. THE CASE WAS AN LVAD (LEFT VENTRICULAR ASSIST DEVICE) INSERTION, THEY WERE ABLE TO COME OFF CPB BUT THE AORTIC ROOT WAS TORE SO THEY HAD TO GO BACK ON CPB. THE OXYGENATOR WAS NOT RECIRCULATED WHILE OFF CPB. DEEP NYPOTHERMIC CIRCULATORY ARREST WAS COMPLETED WHEN THEY RETURNED TO CPB IN ORDER TO REPAIR THE TORN AORTA. THE PATIENT WERE NOT ABLE TO SUCCESSFULLY COME OFF CPB ON LVAD ALONE, RVAD (RIGHT VENTRICULAR ASSIST) DEVICE WAS INSERTED AS WELL. THE PLASMA LEAKAGE AND DETERIORATION OF BLOOD GASES OCCURRED WHEN RETURNING TO CPB THE LAST TIME. THE FIO2 WAS 100% AND THE SWEEP GAS WAS TURNED UP TO 10 LPM. MULTIPLE BLOOD GASES WERE PERFORMED DUE TO THE CONCERNS ABOUT THE OXYGENATOR PERFORMANCE. THEY WERE CONTEMPLATING CHANGING OUT THE OXYGENATOR BUT THE PATIENT WAS ALMOST WARM SO ANESTHESIA VENTILATED WHICH PROVIDED ENOUGH TIME TO FINISH WARMING THE PATIENT AND THE TEAM DECIDED TO JUST COME OFF CPB SINCE THE HEART WAS BEATING INSTEAD OF CHANGING OUT THE OXYGENATOR. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10012235 ↗
• MalfunctionApr 15, 2020Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS FOR A MITRAL VALVE REPLACEMENT (MVR), THE OXYGENATOR HAD A VERY HIGH PRESSURE (400MM) DURING THE LAST PART OF THE CASE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9962443 ↗
• MalfunctionApr 10, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRE CARDIOPULMONARY BYPASS, THE OXYGENATOR CLOTTED. IT IS UNKNOWN WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: No Information

  MAUDE report 9949213 ↗
• MalfunctionNov 1, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A LEAK THAT CAME OUT OF A TUBING "PIGTAIL" CONNECTED TO THE OXYGENATOR. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 9268615 ↗
• MalfunctionOct 24, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE OXYGENATOR LEAKED AND THE SURGEONS CAN NOT PERFORM THE PROCEDURE WITH IT. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: No Information

  MAUDE report 9232643 ↗
• MalfunctionOct 6, 2019Break; Break

  ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE USER FACILITY. THE EVENT OCCURRED AFTER CARDIOPULMONARY BYPASS. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, THE PRODUCT WAS NOT CHANGED OUT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO BLOOD LOSS.

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

  MAUDE report 9160295 ↗