CAPIOX®FX CX*FX15RW40Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04987350701121), received between Dec 18, 2019 and May 15, 2026 — classified as 6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Material Deformation

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE STERILE PACKAGING BAG WAS DAMAGED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186239 ↗
• MalfunctionMar 5, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE OXYGENATOR BLOOD INLET WAS FRACTURED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, THERE WAS NO PATIENT INVOLVED OR HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525794 ↗
• MalfunctionNov 12, 2024Packaging Problem; Packaging Problem

  THE USER FACILITY REPORTED THAT THE ASEPTIC PLASTIC BAG SWELLED, AND GAS ENTERED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662058 ↗
• InjuryOct 30, 2024Failure to Deliver; Failure to Deliver

  THE USER FACILITY REPORTED THAT LOW OXYGENATION. THE CAPIOX WAS USED FOR A VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE SURGERY. AFTER INITIATION BYPASS, THE CAPIOX DID NOT FUNCTION PROPERLY. AFTER FIVE (5) MINUTES INTO FULL BYPASS OXYGENATION DROPPED DESPITE INCREASING THE FIO2 TO 100 PERCENT AND INCREASING THE SWEEP GAS RATION TO 2:1. CPB WAS TERMINATED AND ABG ANALYSIS WAS DONE WHICH SHOWED PO2 OF 210MMHG WITH 100 PERCENT FIO2 AND RE-ESTABLISHMENT OF CPB WAS CARRIED OUT; HOWEVER, IT OCCURRED HAPPENED. THE OXYGENATOR WAS REPLACED WITH A NEW ONE. THERE WAS A LONGER DURATION OF SURGERY RESULTING IN LONGER CPB TIME AND CROSS CLAMP TIME. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT SERIOUSLY HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566502 ↗
• MalfunctionOct 25, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  THE USER FACILITY REPORTED THAT THEY HAD A BROKEN INLET. THE OXYGENATOR IS USING IN CARDIAC SURGERY WHILE IN THE MOMENT PRIMING THE TUBE IS LEAKAGE AND IT FOUND THE "IN" INLET WATER IS BROKEN. REPLACED WITH A NEW CAPIOX. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533115 ↗
• InjuryJun 25, 2024Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED HIGH PRESSURE INVOLVING THE CAPIOX DEVICE. PRIOR TO COMMENCING CARDIOPULMONARY BYPASS, THE PATIENT WAS ADEQUATELY ANTICOAGULATED WITH AN INITIAL PRE-BYPASS ACT OF OVER 400S WITH AN ADDITIONAL 15,000IU OF HEPARIN CIRCULATING WITHIN THE PUMP. WITHIN TEN (10) MINUTES OF COMMENCING BYPASS, A STEADILY INCREASING PRE-MEMBRANE PRESSURE WAS NOTED WITH NO CHANGE IN POST-MEMBRANE PRESSURE LEADING TO AN INCREASING DELTA P. AT THE TIME DELTA P WAS NOTED TO BE ABOUT 150MMHG. AN ABG WAS TAKEN, SHOWING A PAO2 OF 336MMHG ON 100% FIO2, WHICH WAS UNUSUALLY LOW. PRE AND DELTA MEMBRANE PRESSURES CONTINUED TO RISE, THE PATIENT WAS HEMODILUTED, FURTHER HEPARIN WAS ADDED TO THE PUMP AND EPOPROSTENOL WAS ADDED FOR ITS ANTI-PLATELET ACTIVITY. AFTER THIS POINT, PRESSURE (DELTA P >250MMHG, PRE-MEMBRANE PRESSURE >430MMHG). A DECISION TO CHANGE OXYGENATOR WAS MADE. THEY BEGAN TO LIMIT THE AMOUNT OF FLOW THEY COULD PROVIDE TO THE PATIENT, AND VISIBLE FIBRIN STRANDING WAS VISUALIZED WITHIN THE FX-15 OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT SERIOUSLY HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607806 ↗
• MalfunctionFeb 29, 2024Break; Connection Problem; Break; Connection Problem

  THE SCIENTIFIC RESEARCH INSTITUTE REPORTED THAT THE INVOLVED CAPIOX DEVICE OXYGENATOR WAS BROKEN. THE PROBLEM WAS DETECTED WHEN UNPACKING OXYGENATORS FROM THE OUTER PACKAGE. ON TWO SAMPLES FROM THE SAME BOX, THERE WAS A BROKEN PURGE LINE PORT AND DISCONNECTED PURGE LINE AT THE PLACE OF ITS CONNECTION WITH OXYGENATOR BODY. THIS COULD NOT BE OCCURRED DURING TRANSPORTATION (NO VISIBLE SIGNS) OR REMOVING OXYGENATOR FROM THE BOX. THE HOSPITAL IS ACTIVE USER OF CAPIOX FX OXYGENATORS AND HANDLES THEM WITH CARE, SO AN INTENTIONAL DAMAGE IS EXCLUDED. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813577 ↗
• MalfunctionFeb 26, 2024Break; Break

  TERUMO MEDICAL RECEIVED AN EMAIL VIA DISTRIBUTOR MEDILANS FROM KEMEROVO SCIENTIFIC RESEARCH INSTITUTE ON THE BROKEN OXYGENATORS. THE PROBLEM WAS DETECTED WHEN UNPACKING OXYGENATORS FROM THE OUTER PACKAGE. ON TWO SAMPLES FROM THE SAME BOX, THERE WAS A BROKEN PURGE LINE PORT AND DISCONNECTED PURGE LINE AT THE PLACE OF ITS CONNECTION WITH OXYGENATOR BODY. ACCORDING TO CHIEF OF ANESTHESIOLOGY DEPARTMENT, THIS COULD NOT BE OCCURRED DURING TRANSPORTATION (NO VISIBLE SIGNS) OR REMOVING OXYGENATOR FROM THE BOX. THE VENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777328 ↗
• MalfunctionOct 18, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX FX15 OXYGENATOR INVOLVED LEAKED AT THE CONNECTOR SITE DURING PRIMING. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623742 ↗
• InjuryAug 19, 2022Obstruction of Flow; Obstruction of Flow

  THE USER FACILITY REPORTED DURING AN INTERVIEW WITH THE HOSPITAL'S PERFUSIONIST THAT HAD A PATIENT WHO UNDERWENT REOPERATION FOR ASCENDING AORTA REPLACEMENT WITH A DACRON GRAFT, WHO WAS ADMITTED DUE TO THE PRESENCE OF BLEEDING AT THE SITE OF THE SURGICAL WOUND. THEY STARTED WITH OPENING THE SURGICAL WOUND, OBSERVED AN INCREASE OF BLEEDING, SO THEY DECIDE TO CANNULATE IT THROUGH THE FEMORAL VEIN AND ARTERY AND PUT IT ON AN EXTRACORPOREAL CIRCULATION PUMP. ASSISTED WITH A VENOUS DRAINAGE (AVD) WITH AN AMVEX DEVICE TO REGULATE THE VACUUM PRESSURE, MONITORING THE NEGATIVE PRESSURE WITH A PRESSURE TRANSDUCER CONNECTED DIRECTLY TO THE EXTRACORPOREAL CIRCULATION PUMP. THE PRESSURE WAS MAINTAINED AT -40 MMHG AND ITS MAXIMUM PRESSURE SOMETIMES REACHED UP TO 80 MMHG. HALFWAY THROUGH THE SURGERY, A BUBBLE FORMATION WAS OBSERVED IN THE OXYGENATOR RESERVOIR, WHICH DISAPPEARED AND WOULD REFORM SEVERAL TIMES. THE APPEARANCE AND ELIMINATION OF BUBBLES WAS OBSERVED AND THE RESERVOIR CONTRACTS AS THIS CONNECTED TO NEGATIVE PRESSURE. A CIRCULATORY ARREST WAS PERFORMED DUE TO A SURGICAL COMPLICATION, LOWERING THE TEMPERATURE TO 18° C, DURING WARM-UP PRESENTING PROBLEMS IN RAISING THE TEMPERATURE, SINC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15259403 ↗
• InjuryJul 29, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THERE WERE ISSUES WITH THE INVOLVED CAPIOX FX15 DEVICE DURING PRIMING. THERE WAS A LATENCY IN THE PASSAGE OF PRIMING THE CARDIOTOMY FILTER. THEREFORE, THE USER DECIDED TO REPLACE THE DEVICE. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129209 ↗
• InjuryMar 2, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX OXYGENATOR HAD A LEAKING ISSUE, IN THE OXYGENATION MEMBRANE AREA. THEY CHANGED THE OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657357 ↗
• InjuryMar 2, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX OXYGENATOR HAD A LEAKING ISSUE, IN THE OXYGENATION MEMBRANE AREA. THEY CHANGED THE OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654608 ↗
• MalfunctionJan 7, 2022Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. THE PEDIATRIC MEMBRANE OXYGENATOR MODEL W40 - TERUMO WAS USED IN A SURGERY OF A CONGENITAL PATIENT, WITH EBSTEIN'S ANOMALY, AT (B)(6). AFTER A PERIOD OF CARDIOPULMONARY BYPASS, WHERE IT HAD ALREADY BEEN PERFORMED A DEL NIDO AORTIC CLAMPING AND CARDIOPLEGIA, IT BEGAN TO LEAK A "FOAM" THROUGH THE QUICK COUPLING CONNECTOR (NEXT TO THE CAVA TUBES CONNECTION). THE PREPARATION AND PRIME OF THE CIRCUIT WERE CARRIED OUT IN THE USUAL WAY AND IN ACCORDANCE WITH THE INSTITUTION'S PROTOCOL. DURING THE INTERCURRENCE WITH THE AFORE MENTIONED MATERIAL, IT WAS OBSERVED THAT THERE WAS A VARIATION IN THE AMOUNT OF FOAM THAT LEAKED ACCORDING TO THE AMOUNT OF VOLUME IN THE VENOUS RESERVOIR, IF THE VOLUME IN THE VENOUS RESERVOIR WAS BELOW THE MESH (BLOOD VOLUME FILTER THAT ARRIVES FROM THE ARMHOLES), THE AMOUNT OF FOAM COMING OUT WAS IN A SMALLER AMOUNT, AS WELL AS THE OPPOSITE, THE GREATER THE AMOUNT OF VOLUME IN THE VENOUS RESERVOIR (ABOVE THE MESH), THE GREATER THE AMOUNT OF FOAM. IT WAS ALSO OBSERVED THAT IF SOME AMOUNT OF AIR CAME THROUGH THE VENOUS DRAINAGE TUBES, THE AMOUNT OF FOAM ALSO INCREASED. FOR SAFETY REASONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13189983 ↗
• MalfunctionNov 18, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING A HEART TRANSPLANT CASE. DURING CPB, ACT ABOVE 750S, HCT 20-26. ABOUT 5 HRS CPB START, THE PERFUSIONIST FOUND BUBBLES WITH PLASMA AROUND GAS OUTLET, PCO2 INCREASE AND PO2 DECREASE. HE ADJUSTED FIO2 TO 100%, PO2 COULD BE MAINTAINED 92 MMHG UNTIL CPB STOP. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834559 ↗
• MalfunctionAug 25, 2021Break; Break

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT. DURING SET UP, THE USER FOUND THAT THE SAMPLING MANIFOLD WAS BROKEN. THEY DECIDED TO NOT USE THIS ITEM AND CHANGE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364259 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DURING SET-UP OF THE INVOLVED CAPIOX DEVICE, THEY NOTICED THE LONG FILTER INSIDE THE RESERVOIR WAS CRUMPLED AND WAS NOT AS USUAL, WHICH IS NORMALLY STRAIGHT. THE PERFUSIONIST DECIDED TO CHANGE THE OXYGENATOR BEFORE THEY PRIMED IT, AS THEY ARE WORRIED IT MAY HAVE CAUSED UNWANTED TURBULENCE DURING USAGE. THERE WAS NO PATIENT INVOLVED AND THE AFFECTED. THE ACTUAL SAMPLE WAS CHANGED OUT, AND THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9488371 ↗