CAPIOX®FX CX*FX25WRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04987350701084), received between Jul 7, 2016 and Dec 3, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Material Deformation; Material Deformation

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. FLUID WAS COMING OUT OF THE HOUSING. THE EVENT OCCURRED AFTER CARDIOPULMONARY BYPASS. THE EVENT DID NOT RESULT IN DELAYS WITH THE SURGICAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23707001 ↗
• MalfunctionNov 17, 2025Leak/Splash; Leak/Splash

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. FLUID CAME OUT OF THE HOUSING. IT WAS NOTICED JUST BEFORE THE PATIENT CAME OFF BYPASS. WHEN THE PROBLEM OCCURRED WAS UNKNOWN; HOWEVER, THERE WAS NO DELAY IN BEGINNING OR CONTINUING THE PROCEDURE. THE PRODUCT WAS NOT CHANGED OUT. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572125 ↗
• MalfunctionNov 8, 2024Break; Leak/Splash; Break; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED ON 30OCT2024: THE CUSTOMER WAS COMPLAINING OF FIBER BREAKAGES, WHICH WOULD CAUSE A BLOOD LEAKAGE AS A RESULT AND NO PLASMA LEAKAGE. THE DEVELOPMENT OF PLASMA LEAKAGE IS BASED ON OTHER CAUSES, E.G. BLOOD PLASMA IS ABLE TO PENETRATE THE FIBER WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642108 ↗
• MalfunctionNov 8, 2024Break; Leak/Splash; Break; Leak/Splash

  THE USER FACILITY REPORTED THAT THE OXYGENATOR HAD A PLASMA-LEAKAGE (FIBER BREAKAGE). THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 30OCT2024: INITIALLY IT WAS REPORTED THERE WAS AN ISSUE WITH PLASMA-LEAKAGE, HOWEVER THE ACTUAL ISSUE WAS FIBER BREAKAGES, WHICH WOULD CAUSE A BLOOD LEAKAGE AS A RESULT AND NO PLASMA LEAKAGE. THE DEVELOPMENT OF PLASMA LEAKAGE IS BASED ON OTHER CAUSES, E.G. BLOOD PLASMA IS ABLE TO PENETRATE THE FIBRE WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641954 ↗
• MalfunctionOct 17, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED OXYGENATOR WAS BROKEN. THE EVENT OCCURRED DURING PRIME. THE EVENT DID NOT RESULT DID NOT RESULT IN DELAY IN THE BEGINNING OR CONTINUING OF THE SURGICAL PROCEDURE. THE LOCATION OF THE BREAK WAS UNKNOWN, THEY ONLY SAW A LEAK DURING PRIMING. THEREFORE, THE DEVICE WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY. NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471955 ↗
• MalfunctionApr 18, 2024Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX FX25 DEVICE HAD DEFORMED CONNECTORS TO THE HEATER COOLER. THE EVENT OCCURRED DURING SET-UP. THERE ARE NO DELAYS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT ISSUE AND NO BLOOD LOSS REPORTED. THE PRODUCT WAS CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140777 ↗
• InjurySep 15, 2023Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED PAO2 WENT FROM 300 TO 100. THE EVENT OCCURRED DURING A CARDIOPULMONARY BYPASS. THERE WAS NO DELAY IN THE PROCEDURE SURGERY AND WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE BLOOD LOSS WAS LESS THAN 100 CCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761135 ↗
• MalfunctionAug 10, 2023Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE INVOLVED OXYGENATOR PLASMA LEAKED. OCCURRENCE OF THE PLASMA LEAK WAS AFTER 288 MINUTES, BYPASS TIME. SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO RISK OR HARM TO THE PATIENT AT ANY TIME. ADEQUATE OXYGENATION AND CO2 ELIMINATION WAS ALWAYS PRESENT. CHRONOLOGICAL SUPPLEMENTAL PROTOCOL TO THE CASE. DUE TO ANOTHER EMERGENCY SURGICAL INTERVENTION, THE SAME SET-UP, WITH THE ALREADY KNOWN PLASMA LEAKAGE, WAS USED DUE TO TIME CONSTRAINTS. TOTAL BYPASS TIME WAS 318 MINUTES: 20:00 O'CLOCK: TAKEOVER OF THE EXTRACORPOREAL CIRCULATION (ECC) 20:03 O'CLOCK: INFORMATION TO THE SURGICAL TEAM BY SURGEONS ABOUT ANOTHER EMERGENCY SURGICAL INTERVENTION USING EXTRACORPOREAL CIRCULATION. HEPARIN 5,000 IU AD HLM-PRIMING WITH SUBSEQUENT CIRCULATION. HEPARIN INITIAL DOSE WAS 25,000 IU THROUGH ANESTHESIA. 20:04 O'CLOCK: BOTH COMMAND "ASPIRATOR ON" (WITHOUT ACT (ANTICOAGULATION) CONTROL AND/OR WAITING FOR THE EFFECT OF HEPARIN) AND COMMAND "BYPASS START" FULL DRAINAGE VIA VAVD (VACUUM-ASSISTED VENOUS DRAINAGE) ACCORDING TO THE SURGEON, DUE TO AN ACUTE BLEEDING SITUATION. 20:00 O'CLOCK: GOOD OXYGENATION AND DECARBONIZATION CONTINUED DESPITE KNOWN AND ONGOING PLASMA LEAKA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17505914 ↗
• InjuryJul 19, 2022Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED THAT DUE TO A HIGH PRESSURE DROP OF THE OXYGENATING CHAMBER OF ANOTHER COMPANY, AFTER 100 MINUTES OF CEC, THE DEVICE WAS REPLACED WITH AN OXYGENATING CHAMBER FX25W. AFTER 40 MINUTES OF THE REPLACEMENT, THERE WAS A NEW PRESSURE INCREASE ENTERING THE OXYGENATOR UP TO A VALUE OF ABOUT 515 MMHG AFTER ABOUT 90 MINUTES; AT THIS POINT THE CUSTOMER OPTS FOR A THIRD CHANGE OF OXYGENATING CHAMBER BY MOUNTING AN ADDITIONAL FX25W WITH WHICH HE CONCLUDES THE INTERVENTION. ACT VALUES HAVE ALWAYS REMAINED WITHIN THE PHYSIOLOGICAL RANGES FOR EXTRACORPOREAL CIRCULATION. THE PROCEDURE PERFORMED WAS MITRALIC VALVE REPLACEMENT AND AORTO-CORONARY BYPASS GRAFT. THIS CAUSED A DELAY IN THE SURGICAL PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY, HOWEVER, THE PATIENT WAS IN THE OPERATING ROOM (O.R.) A SECOND TIME DUE TO SURGICAL PROBLEMS. THERE WAS NO BLOOD LOSS EXCEPT WHAT WAS INSIDE THE REPLACED OXYGENATOR. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. SINCE THE PRODUCT WAS MALFUNCTIONED DUE TO INCREASED PRESSURE, IT WAS REPLACED. THE FINAL PATIENT IMPACT WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15050843 ↗
• MalfunctionDec 9, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE PRIME LINE ON THE CAPIOX FX OXYGENATOR WAS BROKEN OUT OF BOX. IT WAS NOT NOTICED UNTIL PRIME SOLUTION WAS ADDED AT 8:00 AM. THE PROBLEM OCCURRED OUT OF THE BOX. THERE WAS NOT A DELAY WITH THE PROCEDURE DUE TO THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9438468 ↗
• MalfunctionSep 27, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAK IN THE CAPIOX DEVICE DURING PRIMING. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THERE WAS A LEAK AT THE RECIRCULATION LINE AT THE TOP OF THE OXYGENATOR DURING PRIMING; THE UNIT WAS CHANGED OUT; THE CASE WAS SUCCESSFULLY COMPLETED; AND THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6896797 ↗
• MalfunctionApr 27, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAK IN THE CAPIOX DEVICE DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: A LEAK WAS NOTED AT THE ARTERIAL PORT CONNECTION; THE OXYGENATOR WAS CHANGED OUT; THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6526211 ↗
• InjuryFeb 13, 2017Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED INSUFFICIENT BLOOD FLOW ON THE CAPIOX DEVICE DURING CARDIOPULMONARY BYPASS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THERE WAS A FORWARD FLOW OF A CIRCUIT ISSUE; THE PERFUSIONIST INITIATED HAND CRANKING, THEN CHANGED OUT CIRCUIT; THERE WAS A DELAY IN THE PROCEDURE BY APPROXIMATELY TWO MINUTES; BLOOD LOSS WAS REPORTED TO BE OVER 200 ML; THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss

  MAUDE report 6325331 ↗
• MalfunctionJul 7, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAK IN THE FX25 CAPIOX DEVICE PRE CARDIOPULMONARY BYPASS. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PRODUCT WAS CHANGED OUT; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5774757 ↗