CAPIOX®FX CX*FX15ERecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04987350701183), received between Jan 27, 2016 and Mar 5, 2026 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Improper Flow or Infusion

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR EXPERIENCED A SUDDEN DROP IN PUMP FLOWS; POTENTIAL HPE SITUATION. 45 MINUTES POST XCLAMP, FLOWS SUDDENLY DROPPED TO ABOUT .8 C.I. THERE WERE NO KINKS IN THE A LINE OR THE CANNULA. OXYGENATION, CO2, AND ACTS REMAINED NORMAL. REWARMING WAS ATTEMPTED WITH REPOSITIONING OF THE XCLAMP WITH NO CHANGE. RPMS WERE MAXED AND WITH VERY LOW FLOWS. FEMORAL CANNULATION WAS ATTEMPTED WITH NO CHANGE. THE FLOW PROBE WAS REPOSITIONED WITH NO CHANGE. A NEW PUMP WAS BROUGHT IN AND NORMAL FLOWS WERE RESUMED; THE PROCEDURE WAS COMPLETELY SUCCESSFULLY. THE PATIENT EXPERIENCED LOW FLOWS FOR 18 MIN WITH SYSTOLIC PRESSURES IN THE 30'S. THE PATIENT HAD POLYCYTHEMIA VERA WHICH CARRIES AN INCREASED RISK OF CLOTTING ON BYPASS EVEN WITH PROPER ACT LEVELS. THE CUSTOMER WAS SUSPICIOUS OF HIGH-PRESSURE EXCURSION. THE EVENT RESULTED IN DELAYS OF THE SURGICAL PROCEDURE. 800 ML OF BLOOD LOSS WAS A RESULT OF THE REPORTED ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24520769 ↗
• MalfunctionDec 27, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  THE USER FACILITY REPORTED THAT THE SAMPLE MANIFOLD CAME APART IN THE PACKAGING. THE EVENT OCCURRED OUT OF THE BOX. THE EVENT DID NOT RESULT IN A DELAY IN THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401224 ↗
• InjuryOct 1, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT DURING CARDIOPULMONARY BYPASS, THE CAPIOX DEVICE FAILED TO OXYGENATE AFTER REMOVING THE CROSS PLANT. THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REPORTED EVENT DID NOT CAUSE A DELAY WITH CONTINUING THE PROCEDURE. THERE WAS 150ML BLOOD LOSS AS RESULT; THERE WAS NO INJURY DUE TO THE EVENT.

  Patient problems: Blood Loss

  MAUDE report 9139578 ↗
• MalfunctionMar 21, 2019Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX FX OXYGENATOR'S WATER PORT WAS MISSHAPEN AND APPEARED TO BE MELTED. THE PROBLEM OCCURRED DURING SET UP. THE PRODUCT WAS CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE SERIOUS INJURY, AND THERE WAS NO BLOOD LOSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440308 ↗
• InjuryJan 25, 2019Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED AN OXYGENATOR FAILURE WITH THE INVOLVED CAPIOX FX15 DEVICE DURING CARDIOPULMONARY BYPASS. THE DEVICE WAS CHANGED OUT FOR A CAPIOX FX25 DEVICE. THERE WAS NO BLOOD LOSS OR PATIENT INJURY, AND THE PATIENT DID OK. THE CASE WAS TO REMOVE RIGHT ATRIAL MASS. INDEX FLOW: 4.7L/MIN. PRE-CHECKED CANNULA FLOW: OK. ACTIVATED CLOTTING TIME (ACT): 413SEC. PLATELETS (PLT): 365K, HEMATOPOIETIC CELL TRANSPLANTATION (HCT): 47, BODY SURFACE AREA (BSA): 1.94, 2,4. GAVE 15K HEPARIN MORE PLUS 10K HEPARIN IN CPB. WENT ON BYPASS, FLOW WAS UP TO 4L/MIN, RPM OF 2300; A RESISTANCE OF 185MMHG; STAYED WARM. FOUR MIN INTO IT, THE FLOW WAS NOTICED TO BE GETTING LOW; TO AROUND 3.2. RAN THE ACT: 970SEC. RPM WAS INCREASED FROM 2300 TO 3500, (MAX), FLOW OF 3L/MIN; A RESISTANCE OF 135. SURGEON WAS ASKED IF THERE WAS A KINK OR ANY ISSUE WITH THE CANNULA, NEGATIVE FOR EITHER. THE OXYGENATOR SIDE WAS CHECKED, THERE WAS NO KINK. THE BYPASS LINE WAS OPENED, THERE WAS NO RESISTANCE. CALCULATED POSSIBLE PROTEIN BUILDUP OR EXCESS PLATELET COATING DUE TO SIRS. THEY DECIDED TO CHANGE OUT THE OXYGENATOR RATHER THAN WAITING IT OUT. CAME OFF BYPASS AT 1436; CHANGED OUT THE OXY; TOOK FIVE MIN; WENT ON BYP

  Patient problems: No Information

  MAUDE report 8277413 ↗
• MalfunctionNov 16, 2018Collapse; Collapse

  THE USER FACILITY REPORTED THAT DURING PRIME, THE TUBING WAS PINCHED ON THE ARTERIAL SAMPLING LINE. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077365 ↗
• MalfunctionNov 12, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING PRIME, THE CAPIOX DEVICE WAS LEAKING AT THE PURGE/CONNECTION OF OXYGENATOR BASE, ON TOP OF THE OXYGENATOR. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059358 ↗
• InjurySep 25, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED THAT DURING A CARDIOPULMONARY BYPASS THE ABG PO2 WAS ONLY IN THE MID 70S ON 100% FI02 PER BOTH THE CDI AND ISTAT. IT WAS REPORTED "FOLLOWING A LONG, BUT UNEVENTFUL BYPASS RUN USING AN FX15, IT WAS DEEMED NECESSARY TO RETURN TO BYPASS. AFTER RETURNING TO BYPASS TO REPAIR A BYPASS GRAFT, THE OXYGENATOR DID NOT PERFORM AS EXPECTED. ABG PO2 WAS ONLY IN THE MID 70S ON 100% FIO2 PER BOTH THE CDI AND ISTAT. PALLIATIVE MEASURES SUCH AS SHUNTING THROUGH THE RECIRCULATION LINE, SWITCHING TO A PORTABLE 02 TANK, ETC DID NOT HELP. THE SURGEON AND THE ANESTHESIA WERE NOTIFIED AS SOON AS THE ISTAT WAS AVAILABLE (THIS WAS CHARTED). PARTIAL BYPASS WITH VENTILATOR SUPPORT (PER MUTUAL DECISION) WAS INITIATED SINCE THE SECOND BYPASS RUN WAS EXPECTED TO BE SHORT (IT WAS 12 MINS). ANOTHER VERY BRIEF RUN WAS NEEDED, AND PARTIAL SUPPORT WAS AGAIN INITIATED. AFTER PROTAMINE ADMINISTRATION, IT WAS SUGGESTED TO THE SURGEON THAT I SHOULD IMMEDIATELY DISPOSE OF THIS CIRCUIT AND RAPIDLY SETUP ANOTHER, WITH AN FX25 OXYGENATOR. HE AGREED THAT THIS WAS THE SAFEST OPTION, AND WITH THE ASSISTANCE WE DID THIS. NO FURTHER BYPASS WAS NEEDED, AND NO ADVERSE EVENTS WERE OBSERVED." THE PRODUCT W

  Patient problems: No Information

  MAUDE report 7906422 ↗
• InjuryJul 6, 2018Connection Problem; Connection Problem

  THE USER FACILITY REPORTED A CONNECTION FAILURE WITH THE INVOLVED CAPIOX FX OXYGENATOR. BEFORE WEANING THE PATIENT OFF THE EXTRACORPOREAL CIRCULATION, IN ORDER TO COLLECT BLOOD CONTAINED IN THE CARDIOPLEGIA CIRCUIT, THE CUSTOMER UNCLAMPED THE BLOOD CARDIOPLEGIA PORT, WHEN THE TUBE CONNECTED TO THE BLOOD CARDIOPLEGIA PORT CAME OFF. THE BACK PRESSURE WAS APPROXIMATELY 200MMHG. THE JOINT OF THE TUBE AND PORT HAD BEEN TIE-BANDED FIRMLY. IMMEDIATELY AFTER THE TUBE HAVING COME OFF, THE CUSTOMER STOPPED THE PUMP AND APPLIED FORCEPS WITHIN 20 SECONDS. THE AMOUNT OF BLOOD LOSS AND THE PROCEDURE OUTCOME WAS UNKNOWN. THE PATIENT WAS REPORTED TO BE GETTING BETTER.

  Patient problems: Blood Loss

  MAUDE report 7666173 ↗
• InjuryApr 9, 2018Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED DURING AN AORTIC VALVE SURGERY: WHILE BEING ON BYPASS, THE DELTA PRESSURE INCREASED FROM 60 MMHG TO 250 MMHG. THE FIRST PART OF THE SURGERY WAS TERMINATED WITH THE SAME INVOLVED OXYGENATOR. AFTER TERMINATING THE BYPASS AND SURGERY, THE SURGEON DETECTED ANOTHER PROBLEM WITH THE PATIENT'S HEART AND DECIDED TO GO AGAIN ON BYPASS. THEY CHANGED THE OXYGENATOR BEFORE THEY STARTED AGAIN. THERE WAS NO ADVERSE IMPACT FOR THE PATIENT BECAUSE OF THE OXYGENATOR. THE PROCEDURE OUTCOME AND PATIENT'S CONDITION WAS REPORTED TO BE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7409372 ↗
• MalfunctionFeb 15, 2018Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED AFTER ONE HOUR ON BYPASS, THE DELTA PRESSURE RAISED TO 390MMHG. THE FLOW WAS AT 3,8 LPM. THE OXYGENATION WAS GOOD, AND THE PATIENT WAS OK. HOWEVER, THE PERFUSIONIST HAD SOME CONCERNS, HE THOUGHT THE OXYGENATOR COULD FAIL OR THE PRESSURE COULD BE TOO HIGH FOR THE PATIENT'S BLOOD. THE SURGERY WAS TERMINATED, AND THE FLOW REDUCED TO 3,2 LPM. NO ADVERSE REACTION COULD BE DETECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7273329 ↗
• MalfunctionSep 19, 2017Leak/Splash

  THE USER FACILITY REPORTED A LEAK IN THE CAPIOX DEVICE DURING PRIMING. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A SMALL LEAK WAS NOTED ON THE CLEAR PLASTIC STUB OFF THE ARTERIAL OUTLET THAT CONNECTS TO THE WHITE PLASTIC PORTION BEFORE THE SAMPLING MANIFOLD LUERS; THE DEVICE WAS CHANGED OUT; AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6876351 ↗
• InjuryFeb 24, 2017Filtration Problem; Filtration Problem

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE CLOTTED OFF DURING CARDIOPULMONARY BYPASS. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PRODUCT WAS CHANGED OUT; REPORTED BLOOD LOSS WAS ABOUT 200ML; THERE WAS A NINE MINUTE DELAY; AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS PROVIDED BY THE CHIEF PERFUSIONIST ON 1/26/2017: THE PATIENT WAS A (B)(6) MALE. HE HAD A BSA OF 2.37 AND HE WAS QUITE MUSCULAR. THIRTY THOUSAND UNITS OF HEPARIN WAS GIVEN AT 10:40 AM. AT 10:53 AN ACT WAS DRAWN AND IT WAS 383 SECONDS (LOW). FIVE MINUTES LATER THE ANESTHESIA RESIDENT GAVE ANOTHER TEN THOUSAND UNITS OF HEPARIN AND THE ENSUING ACT WAS 440 SECONDS. WE WERE READY TO GO ON BYPASS. THE PERFUSIONIST PUT AN EXTRA FIVE THOUSAND UNITS IN THE PRIME. THIS PATIENT HAD BEEN IN HOUSE AND ON A HEPARIN DRIP FOR DAYS. WHILE THE SURGEON CANNULATED AND CHECKED THE VEIN NEARLY FIFTY MINUTES PASSED. WE WENT ON BYPASS AT 11:30 AND THE FIRST ACT ON BYPASS WAS 425. WE CROSS CLAMPED THE AORTA AT 11:35. EIGHT HUNDRED FIFTY CCS OF CARDIOPLEGIA WAS IN BY 11:39. OVER A FEW MINUTES THE FLOW DROPPED FROM 4.7 LITERS PER MINUTE TO 1.0 LITER PER MINUTE. THE CEN

  Patient problems: Blood Loss

  MAUDE report 6358296 ↗
• MalfunctionFeb 17, 2017Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED PRESSURE INCREASE IN THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PRESSURE INCREASED IN THE OXYGENATOR UP TO 250 DELTA P; PROCEDURE WAS AN AORTIC AND MITRAL VALVE WITH BYPASS; PRESSURE INCREASE WAS NOTICED AFTER 80% OF BYPASS TIME; THE OXYGENATOR WAS IN USE FOR 2.5 HOURS AND WAS NOT EXCHANGED; AND THE PATIENT WAS TREATED AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6340018 ↗
• MalfunctionJan 26, 2017Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED HIGH RESISTANCE ON THE CAPIOX FX15 DEVICE AFTER CARDIOPULMONARY BYPASS. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: CASE: CAB X 1, NO UNUSUAL PATIENT COAGULATION ABNORMALITIES; 70 MINUTE PUMP RUN AT NEAR NORMOTHERMIA; THERE WERE NO UNUSUAL FINDINGS DURING BYPASS (NORMAL LINE PR AND GAS EXCHANGE); AFTER TERMINATION OF BYPASS AND DECANNULATION OF THE VENOUS LINE, THE REMAINDER OF THE PUMP VOLUME WAS INFUSED THROUGH THE ARTERIAL LINE AND AN ADDITIONAL 500CC OF VOLUME (PLASMALYTE) WAS ADDED TO THE RESERVOIR TO CHASE CIRCUIT BLOOD BACK INTO THE PATIENT; THERE WAS NO EXPOSURE OF THE PUMP TO PROTAMINE; PROTAMINE WAS STARTED AND THE ARTERIAL CANNULA WAS REMOVED; AFTER REMOVAL, IT WAS ROUTINE TO DRAIN BACK THE ARTERIAL LINE TO THE PUMP TO SEQUESTER RESIDUAL RED CELL VOLUME. THIS IS ACCOMPLISHED BY TURNING OFF THE RPM'S ON THE CENTRIFUGAL PUMP AND REMOVING ALL CLAMPS, USING GRAVITY TO ALLOW BLOOD TO DRAIN BACK; AT THIS POINT, THE BLOOD IN THE ARTERIAL LINE WOULD NOT DRAIN BACK INTO THE PUMP; IN ORDER TO RE-ESTABLISH FLOW THROUGH THE OXYGENATOR, THE CUSTOMER OPENED THE RECIRCULATION LINE, CLAMPED THE ARTERIAL LINE, AND TURNED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6281130 ↗
• InjuryNov 17, 2016Obstruction of Flow; Obstruction of Flow

  THE USER FACILITY REPORTED THE OXYGENATOR FLOW SUDDENLY STARTED DROPPING TO WHERE THE CUSTOMER COULD NOT GET ADEQUATE FLOW. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE CUSTOMER WENT ON PUMP TODAY AND FLOW WAS FINE; ALL BLOOD GASSES WERE FINE AND SUDDENLY FLOW STARTED DROPPING AND THE CUSTOMER COULD NOT GET ADEQUATE FLOW; FLOW DROPPED DOWN TO 2 LPM HOWEVER ALL BLOOD GAS LEVELS REMAINED THE SAME AND IN GOOD PARAMETERS; THE CUSTOMER CHANGED OUT THE FX15R IN 2-3 MINUTES WITH NO MAJOR DELAY AND THE PATIENT NEVER LOST OXYGENATION; SVO2 GOT DOWN TO 66 BUT ONCE CHANGED OUT AND BACK ON THE PUMP EVERYTHING WORKED WELL AS USUAL; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6108930 ↗
• InjuryJul 7, 2016Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED INSUFFICIENT GAS EXCHANGE IN THE FX15 CAPIOX DEVICE DURING CARDIOPULMONARY BYPASS. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE FX15 OXYGENATOR WAS FAULTY AND DID NOT ADEQUATELY OXYGENATE THE PATIENT, RESULTING IN A REQUIRED CHANGE OUT; IT WAS REPORTED THAT THE OXYGEN DELIVERY, PRIOR TO BYPASS INITIATION WAS TESTED AND WAS DELIVERING PROPERLY; UPON INITIATION OF BYPASS WITH OXYGEN DELIVERY SET AT 100% AND SWEEP OF 2L, NO COLOR CHANGE WAS NOTICED BETWEEN THE VENOUS AND ARTERIAL LINES, AT WHICH POINT SHUNTS WERE OPENED AND FLOW INCREASED TO RECIRCULATE THE BLOOD THROUGH THE OXYGENATOR TO HELP IMPROVE O2 DELIVERY; FIRST ABG ON BYPASS SHOWED A PAO2 OF ONLY 43MMHG; THE OXYGEN SOURCE WAS THEN CHANGED FROM BLENDER TO AN OXYGEN CYLINDER TO ASSURE IT WAS NOT A FAULTY BLENDER; PAO2 WITH USING THE OXYGEN CYLINDER CAME BACK AT 120 MMHG FOLLOWED BY ANOTHER PAO2 OF 68 SHORTLY AFTER; THE OXYGENATOR CHANGE OUT WAS REQUIRED AND THERE WAS A DELAY OF EIGHT MINUTES DURING THE CHANGE OUT; THERE WAS AN UNKNOWN AMOUNT OF BLOOD LOSS REPORTED; THE PATIENT WAS THEN WEANED FROM BYPASS AND DETERMINED STABLE ENOUGH FOR THE SWITCH; THE PATIEN

  Patient problems: Blood Loss

  MAUDE report 5774753 ↗
• MalfunctionJan 29, 2016Leak/Splash; Leak/Splash

  THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 FOR MFR. REPORT NO. 9681834-2016-00003 TO PROVIDE AN UPDATE ON THE STATUS OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 5399949 ↗
• MalfunctionJan 27, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE IN THE CAPIOX FX15 DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: (1) THE HEATER COOLER OUTLET CONNECTION ON THE OXYGENATOR WAS DAMAGED AND LEAKING DURING SETUP; (2) THE OXYGENATOR WAS CHANGED OUT DURING SETUP; (2) SURGERY WAS COMPLETED SUCCESSFULLY; AND (3) THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5392495 ↗