Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX25RERecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00699753450103), received between Nov 19, 2015 and Jun 10, 2024 — classified as 1 death, 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXY IN LINE BLEW OFF WHILE ON PUMP. *THERE WAS A BLOOD LOSS OF 1500CC *PRODUCT WAS CHANGED OUT *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19505099 ↗
• MalfunctionSep 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NON-CONFORMING LABELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830375 ↗
• MalfunctionJun 7, 2023Break; Break

  MANIFOLD CAPS WERE ALL BROKEN AT THE TOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079312 ↗
• InjuryMar 14, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED BY THE CLINICAL SPECIALIST, FROM THE CHIEF OF PERFUSION STATES THAT, THE CDI550 WAS CALIBRATED AND LAB BLOOD GAS WAS CHECKED THROUGH ISTAT, AND THEY DO NOT FOLLOW DO2S AND VO2S. THE PATIENT WAS CANULATED SPLIT ARTERIAL, ONE TO THE LEG, AND ONE TO THE UPPER BODY; THIS WAS A TYPE 2 THORACOABDOMINAL ANEURYSM. THEY NOTICED THE CHANGE IN THE OXYGENATOR UPON REWARMING. ANOTHER INDICATIONS THAT THERE WERE CHANGES IN THE PATIENT HEMODYNAMICS WERE; WHEN SHE WAS CALLED TO HELP THE PERFUSIONIST DOING THE CASE; AS THE HEMATOCRITS WERE LOW AT 20, THE CEREBRAL SATURATIONS WERE 19 AND THE FLOW TO THE PATIENT WAS LOW, 1 LITER TO THE LEG, AND 2 LITERS TO THE UPPER BODY. THIS IS DICTATED BY THE SURGEON AND DEPENDING ON WHERE HE IS ON THE PROCEDURE. THE ANTICOAGULATION WAS GOOD; ACT¿S ABOVE 1000 THROUGHOUT THE CASE, UNTIL THEY CHANGED OUT THE OXYGENATOR. THEN THEY WERE IN THE 600-700¿S. THEY HAD NO ISSUES WITH ANY OTHER CARDIAC CASES BESIDES THE THORACOABDOMINAL CASES, EVEN WITH ASCENDING DISSECTIONS WITH CIRCULATORY ARREST; FOR THIS IS A 20-YEAR PROGRAM AT THE IU METHODIST. THEY ALSO DID NOT TAKE ANY PVO2 LAB MEASUREMENTS, AND THERE WAS NO DIFFERENCE HAPPENING DURING

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16537190 ↗
• MalfunctionFeb 3, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST, BASED ON THE CONDUCTED PHONE INTERVIEW WITH THE PERFUSIONIST STATES THAT, THE PERFORMANCE AND CHANGE OUT OF THE OXYGENATOR WAS NOT A CAUSE OF THE PATIENT REQUIRING ECMO AT THE END OF THIS VERY LONG, COMPLICATED CASE. THE PATIENT WAS VERY SICK AND WITH A HIGH RISK FOR SURGERY. WHEN ASKED ABOUT THE ANTI-COAGULATION MANAGEMENT OF THE PATIENT, THE PERFUSIONIST VERBALLY COMMUNICATED THAT NUMEROUS ACT VALUES OF 999 SECONDS WERE REALIZED OVER A SIGNIFICANT TIME PERIOD DURING WHICH NO HEPARIN WAS ADMINISTERED. UPON REWARMING THE PATIENT, INTO THE 6-HOUR (360MINUTES) MARK OF THE BYPASS RUN, THE PO2 VALUES STEADILY DECREASED AS THEY INTERMITTENTLY WERE MEASURED ON THE POINT OF CARE BLOOD GAS ANALYZER ( ISTAT ). THE DECISION TO CHANGE OUT THE OXYGENATOR WAS MADE UPON PO2 VALUES IN THE 60S (SIXTIES) MMHG RANGE. AN ENTIRE NEW HEART-LUNG MACHINE, WITH A NEW OXYGENATOR AND TUBING PACK WAS UTILIZED TO PERFORM THE CHANGE-OUT. THE CHANGEOUT WAS UNEVENTFUL AND DONE WITHIN A REASONABLE TIME, AND BYPASS WAS RE-INITIATED WITHOUT ISSUES AS PER THE PERFUSIONIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291808 ↗
• DeathFeb 3, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR INCREASE IN CO2, DECREASE IN O2 (LOWEST PO2 WAS 49). IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE, AND IF THERE WAS ANY BLOOD LOSS. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. AS PER USER FACILITY, THE PATIENT EXPIRED ON THE TABLE, NOT AS A RESULT OF THE OXYGENATOR CHANGE-OUT. ADDITIONALLY, THE CLINICAL SPECIALIST WAS INFORMED BY THE PERFUSIONIST THAT THEY DID NOT COOL THE PATIENT DOWN VERY MUCH COMPARED TO TYPICAL CASES. ACTS WAS UTILIZED FOR THEIR ANTICOAGULATION STATUS, WITH A READING OF 999. THE HEPCON MACHINE WAS NOT USED, AND THEY DID NOT GIVE HEPARIN FOR AN EXTENDED PERIOD OF TIME. THE SHUNT SENSORS WERE ALSO NOT USED DURING THE CASE; THEREFORE, THEY HAD TO SEND BLOOD SAMPLES TO THE LABORATORY OR OBTAIN BLOOD GASES USING POINT OF CARE. WHEN THEY DECIDED TO CHANGE THE OXYGENATOR OUT, THE FAILURE OF THE OXYGENATOR OCCURRED UPON RE-WARMING THE PATIENT AT THE END OF THE CASE. THE PERFUSIONIST WAS ALSO ADAMANT THAT THE DEATH OF THE PATIENT WAS NOT A RESULT OF THE OXYGENATOR FAILURE OR CHANGED OUT. IT WAS COMMUNICATED T

  Patient problems: Cardiac Arrest

  MAUDE report 16291773 ↗
• MalfunctionJan 3, 2023Particulates; Particulates

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A WHITE FLAKE FLOATING IN THE RESERVOIR WAS NOTICED. AS PER THE USER FACILITY, THEY REMOVED THE VENOUS RESERVOIR OUTLET TUBING AND DRAINED THE PARTICULATE PIECE OUT INTO A SPECIMEN CUP. THE OUTLET TUBE WAS REPLACED AND PRIMING WAS FINISHED. THEY WERE ABLE TO RUN THE CIRCUIT WITH NO ISSUES. NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091171 ↗
• InjuryApr 26, 2022Gas Output Problem; Leak/Splash; Gas Output Problem; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS THE OXYGENATOR FAILED. PER USER FACILITY THE PATIENT WAS IN FOR A MINI MITRAL VALVE REPLACEMENT WAS IN FOR A MINI MITRAL VALVE REPLACEMENT WHICH WAS SUCCESSFULLY COMPLETED. HE HAD SEVERE AORTIC INSUFFICIENCY AND THE PUMP SUCKERS WERE TURNED TO A HIGH RPM. THE PATIENT WAS COOLED TO 28C NO XCLAMP, AND COLD FIBRILLATORY ARREST OCCURRED. AFTER 1.5 TO 2 HOURS INTO THE CASE, THE ARTERIAL PCO2 STARTED TO RISE ON THE CDI 500, WITH THE SHUNT SENSOR HAVING UNDERGONE A PASSING 2 POINT CALIBRATION BEFORE BYPASS. THE GAS SWEEP WAS RAISED UP AND OVER 10L/MIN WITH THE EPGS ON SYSTEM 1 HLM WITH NO EFFECT TO LOWER THE PCO2, EVEN AFTER REDUCING CO2 FLUSHING TO THE FIELD. A POINT OF CARE BLOOD GAS ANALYZER CONFIRMED PCO2 IN THE 70S. GAS FLOW WAS CONFIRMED EXITING THE SYSTEM 1 HLM BY THE EXTERNAL FLOWMETER AND ALSO HOLDING THE GAS LINE TO THE EAR FOR THE PHYSICAL PRESENCE OF GAS FLOW OUT FROM THE GAS LINE AND GAS FILTER. THE HEPARINIZATION OF THE BLOOD WAS ADEQUATE AND CONFIRMED BY ACTS AND ALSO HEPARIN CONCENTRATION USING HEPCON. THE DECISION WAS MADE TO GO TO A OXYGEN TANK DIRECTLY TO THE OXYGENATOR AT 15-20 L/MIN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoxia

  MAUDE report 14204061 ↗
• MalfunctionMar 25, 2022Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, NOTICED A NICKEL SIZE AIR BUBBLES OVER WHELM THE AF125 FILTER. AS PER SALES, THE PERFUSIONIST WAS CONDUCTING CHECKLIST SOP AND INITIATED A STOP PUMP PROCEDURE TO CONFIRM IT WAS WORKING. AS A RESULT THE RX25RE HAD NICKEL SIZE AIR BUBBLES OVER WHELM THE AF125 FILTER. THE PERFUSIONIST WAS CONCERNED AND REDID THE STOP FUNCTION SAME RESULTS. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905905 ↗
• MalfunctionDec 3, 2021Precipitate in Device or Device Ingredient; Obstruction of Flow; Precipitate in Device or Device Ingredient; Obstruction of Flow

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY WERE UNABLE TO INJECT AND WITHDRAW FLUID FROM THE PORT OF THE RECIRCULATION LINE FRO THE BOTTOM OF THE OXYGENATOR. PER FACILITY, IT APPEARED THERE WAS ALSO DEBRIS IN THE END OF THE LINE NEAREST TO THE PORT. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927358 ↗
• MalfunctionJul 12, 2021Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THEY NOTICED THE MEMBRANE FILLS WITH SMALL BUBBLES ON PUMP STOP. THE OXYGENATOR WAS ASSEMBLED AND DEBURRED, IT WAS OBSERVED WHEN THE PUMP STOPPED, THE MEMBRANE FILLS WITH SMALL BUBBLES, THE DE-BUBBLING PROCESS WAS REPEATED AND ROLLERS ARE CALIBRATED. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154861 ↗
• MalfunctionFeb 2, 2021Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, BUBBLES WERE SEEN AFTER OXYGENATOR WAS CONNECTED. AS THE OXYGENATOR WAS CONNECTED, THE PASSAGE OF BUBBLES WERE EVIDENT. THE OXYGENATOR WAS CONNECTED TO THE RECIRCULATION LINES OF THE EXTRACORPOREAL CIRCUIT, IT WAS IN THE PROCESS OF PURGING THE CIRCUIT SO IT WAS NOT YET CONNECTED TO THE ARTERIAL CANNULA FOR EXTRACORPOREAL CIRCULATION. THE BUBBLES WERE EVIDENT AT THE EXIT OF THE OXYGENATOR AT THE ARTERIAL PORT OF THE CAPIOX RX 25, REACHING THE LINES OF RECIRCULATION, MANIFOLD AND ARTERIAL FILTER AF125. THE PRIMING ASSIST LINE WAS OCCLUDED. THE ARTERIAL ROLLER PUMP WAS USED, WHEN PERFORMING MANEUVERS TO REDUCE BLOOD FLOW AND INCREASE IT THE BUBBLES WERE PRODUCED. THE FLOW OF THE ARTERIAL ROLLER WAS STOPPED TO PERFORM THE EVALUATION OF POSSIBLE EXTERNAL CAUSES OF AIR EMBOLISM GENERATION AND FOR THE PROCESS OF REPLACING OXYGENATION MEMBRANE WITH A NEW ONE. THE ARTERIAL PUMP WAS OPERATING WITH FLOW ALMOST 2.5LT/MIN, THE ARTERIAL PUMP WAS STOPPED FOR THE OXYGENATOR CHANGE OUT. ALL LUER CONNECTIONS, TUBING CONNECTIONS, STOPCOCKS IN THE CIRCUIT WERE CHECKED TO ENSURE THAT THERE WAS NO AIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268123 ↗
• MalfunctionAug 24, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE BLOOD INLET PORT WAS DISFIGURED AND BENT OUT OF SHAPE. ADDITIONALLY, THE CAP COVERING THE PORT ALSO REFLECTED DAMAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10446507 ↗
• MalfunctionMay 15, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE DISTRIBUTION WAREHOUSE REPORTED TO TERUMO CARDIOVASCULAR UPON RECEIPT, IT WAS OBSERVED THAT THE 1 PIECE BOX HAD NO LABELS. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10063204 ↗
• MalfunctionMar 23, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE SUBSIDIARY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING QUALITY INSPECTION, THEY NOTED THE OXYGENATOR HAD NO LABEL. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9869552 ↗
• MalfunctionMar 2, 2020Packaging Problem; Packaging Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, PRIOR TO CARDIOVASCULAR BYPASS, DURING OUT OF BOX,HOLES WERE NOTICED ON THE BOX UPON RECEIVED. PER USER FACILITY, A FORKLIFT HIT THE BOXES DURING DELIVERY. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9777020 ↗
• MalfunctionOct 4, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING SETUP, NO TEMPERATURE READING FROM ARTERIAL THERMISTER WAS NOTED. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158546 ↗
• MalfunctionSep 30, 2019Component Missing; Component Missing

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT BOX, THE MANIFOLD WAS MISSING FROM THE TOP OF RESERVOIR UPON OPENING THE NEW CXRX25RE BAG. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9136648 ↗
• MalfunctionJul 9, 2019Component Missing; Component Missing

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE SENSOR WAS MISSING. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8774260 ↗
• MalfunctionMar 8, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME A LEAKAGE FROM THE OXYGENATOR WAS NOTICED. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8405651 ↗
• MalfunctionJan 10, 2019Break; Leak/Splash; Break; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE LINE BETWEEN THE BLUE SIDE OF THE MANIFOLD AND THE VENOUS LINE WAS DAMAGED AND FLUID WAS LEAKING OUT FROM THE POINT WHERE THE LINE JOINS THE VENOUS LINE. PER CUSTOMER THE PROBLEM WITH THAT AREA IS THAT HE COULD NOT ATTACH A BUNG BECAUSE WASN'T A LUER LOCK SO HE OPENED A CELL-SAVERS EXTRA PACK, AND FROM THE BLUE SIDE OF THE MANIFOLD THAT USUALLY ATTACHES TO THE WHITE CONNECTOR, HE ATTACHED THIS TO ONE OF THE PORTS ON THE VENOUS LINE. 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 8232849 ↗
• MalfunctionOct 23, 2018Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE CAP ON THE RESERVOIR OUTLET WAS OFF THE PORT. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP PRODUCT WAS CHANGED OUT.. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 7998010 ↗
• MalfunctionOct 8, 2018Break; Leak/Splash; Break; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIMING, THERE WAS A LEAK ON THE OXYGENATOR AND UPON INSPECTION, IT WAS FOUND TO BE BROKEN. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 7944406 ↗
• InjuryNov 19, 2015Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS THE OXYGENATOR DEPRIMED AND AIR WENT UP THE ARTERIAL LINE THROUGH THE ARTERIAL FILTER. THE EVENT OCCURRED DURING A SIX HOUR PUMP RUN (TEN HOURS TOTAL - INCLUDING PRIMING OF THE CIRCUIT) AT THE END OF THE CASE. AIR DID NOT REACH THE PATIENT. THE UNIT WAS CHANGED OUT, BUT THEY DID NOT HAVE TO GO BACK ON PUMP. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. THE DEVICE WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5237986 ↗