CAPIOX®FX CX*FX15RW30Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04987350701169), received between Apr 27, 2016 and Nov 25, 2025 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Pressure 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 16, 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.

• InjuryNov 25, 2025Pressure Problem; Pressure Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE PATIENT HAD CENTRAL CANNULATION. THE SURGERY PROCEEDED NORMALLY; HOWEVER, AFTER 75 MINUTES WITH THE PUMP, BLOOD FOAM APPEARED INSIDE THE OXYGENATOR. DUE TO THE PRESSURE, THE QUICK-FILLING TUBBING POPPED OUT QUICKLY, RESULTING IN BLOOD LOSS. ASSISTED VENOUS DRAINAGE WAS NOT REQUIRED. THE OXYGENATOR WAS REPLACED, WHICH ADDED APPROXIMATELY FIVE MINUTES TO THE PROCEDURE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646830 ↗
• InjuryNov 25, 2025Pressure Problem; Pressure Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. AN ADULT PATIENT WITH PERIPHERAL CANNULATION AND ASSISTED VENOUS DRAINAGE HAD BEEN ON PUMP SUPPORT FOR THREE HOURS. THE MEDICAL TEAM WAS PREPARING TO WEAN THE PATIENT FROM THE PUMP WHEN THE OXYGENATOR BEGAN TO FOAM, CAUSING THE TUBING TO POP OUT. THE OXYGENATOR BECAME PRESSURIZED, RELEASING BUBBLES INTO THE ARTERIAL LINE. THE OXYGENATOR WAS REPLACED, AND RETROGRADE PERFUSION WAS PERFORMED TO REMOVE THE BUBBLES THAT HAD ENTERED. THE PATIENT'S CONDITION WAS ALREADY POOR, AND HE DID NOT SURVIVE. THERE HAD BEEN A CHANGE OF OPERATING ROOM, AND COMMUNICATION INDICATED THAT THE WALL OUTLETS WERE MALFUNCTIONING. THEY WERE PRESSURIZING DUE TO WATER ACCUMULATION OR BLOWING AIR INSTEAD OF ASPIRATING. THIS WAS BELIEVED TO HAVE CAUSED THE DEVICE MALFUNCTION. THE USER ASSUMED THAT THE BLEEDING ISSUE WAS RELATED TO A PROBLEM WITH THE AIR INTAKES RATHER THAN PROPER ASPIRATION. THE OXYGENATOR WAS REPLACED, WHICH ADDED APPROXIMATELY FIVE MINUTES TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23646828 ↗
• InjuryMay 16, 2025Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THERE WAS BLOOD LEAKAGE FROM THE OXYGENATION. DURING THE PROCESS OF MITRAL VALVE MECHANICAL REPLACEMENT SURGERY, IT WAS DISCOVERED THAT THERE WAS BLOOD LEAKAGE FROM THE OXYGENATOR WHILE THE CBP HAD NOT EVEN. ONCE THE MACHINE WAS RUNNING, THE SPEED OF LEAKAGE INCREASED. IN AN EMERGENCY SITUATION, THE OXYGENATOR BIN WAS REPLACED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037113 ↗
• MalfunctionApr 21, 2025Connection Problem; Connection Problem

  THE USER FACILITY REPORTED THAT THE SAMPLING TUBE WAS DISCONNECTED FROM THE BLOOD OUTLET PORT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878787 ↗
• MalfunctionApr 21, 2025Break; Break

  THE USER FACILITY REPORTED THAT THE WATER OUTLET PORT WAS BROKEN. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878786 ↗
• MalfunctionFeb 11, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING PRIMING THE PERFUSIONIST FOUND LEAKAGE FROM THE BOTTOM OF RESERVOIR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356804 ↗
• MalfunctionDec 11, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE INLET OF CAPIOX OXYGENATOR WAS BROKEN. THE PRODUCT WAS NOT USED IN THE CASE SINCE THE ISSUE WAS IDENTIFIED BEFORE PRIMING. THE DOCTOR USED ANOTHER TERUMO OXYGENATOR. 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 20901514 ↗
• MalfunctionMar 5, 2024Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED THAT THEY HAD A CABG CASE ON CPB. PRIMING WITH 500ML GELOFUSINE, HEPARIN 5000 UNIT 350ML MANNITOL (10%) AND 100ML HARTMAN'S. INITIATE CPB WITH ACT MORE THAN 1000 SEC (FLOW 4.5LPM, FIO2 100%, GAS SWEEP 2.5L. ON CPB, ABG SHOWS PAO2 - 63MMHG AND PACO2 421MMHG. WHEN INCREASE GAS SWEEP TO 5L, REPEAT ABG SHOWS PAO2 - 69MMHG. TEST WITH O2 TANK 100% STILL NO CHANGES. PATIENT REPORTED TO BE SAFE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843154 ↗
• MalfunctionMar 10, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE FROM THE ADAPTER OF RESERVOIR DURING PRIMING. THE OPERATOR RECHECKED THE CONNECTION AND REPLACED THE TUBING CONNECTOR; HOWEVER, THE LEAKAGE STILL OCCURRED. THE PRODUCT WAS REPLACED AND THERE WAS NO MORE LEAKAGE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520635 ↗
• MalfunctionSep 20, 2022Gas Output Problem; Gas/Air Leak; Gas Output Problem; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE CAPIOX FX15 OXYGENATOR WAS IN TOF SURGERY. THE CIRCUIT WAS PRIMED AND CHECKED MULTIPLE TIMES FOR ANY LEAKAGE. STERNOTOMY WAS DONE AND CANNULATION ALSO DONE AFTER DIVIDING THE LINE. BEFORE CANNULATING AORTA, THE OCCLUSION WAS CHECKED AGAIN BUT THERE WAS RETROGRADE FLOW OBSERVED IN THE ARTERIAL LINE. PUMP HEAD WAS ALSO CHECKED FOR ANY LEAK OR UNDER OCCLUSION. CIRCUIT WAS CHANGED FOR ANY LEAKAGE IN THE MANIFOLD/SAMPLE LINE, THE RECIRCULATION LINE, THREE WAYS, CARDIOPLEGIA SYSTEM AND THE HEATER COOLER UNIT. DESPITE CHECKING EVERY POSSIBLE CONNECTION, THE RETROGRADE FLOW AND AIR WAS COMING IN THE CIRCUIT FROM UNKNOWN SOURCES. HENCE OXYGENATOR WAS CHANGED AFTER WHICH THE PROBLEM WAS SOLVED, AND NO RETROGRADE FLOW AND AIR WAS SEEN. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT'S FINAL IMPACT WAS NOT HARMED. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457802 ↗
• MalfunctionJul 19, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) THE PERFUSIONIST OBSERVED THE FROTH FORMATION (MEMBRANE LEAK) INSIDE THE OXYGENATOR CHAMBER. THERE WAS ALSO REDUCED OXYGENATION DURING CPB. THE OXYGENATOR WAS NOT REPLACED, AND THE PROCEDURE WAS CONTINUED AS NORMAL. NO EVENT WAS REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051163 ↗
• InjuryDec 22, 2020Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED DURING THE PROCEDURE. HEAD OF DEPARTMENT CARDIO TECHNOLOGY, APPROXIMATELY 30 MIN AFTER THE START OF BYPASS, INCREASE IN PRESSURE IN FRONT OF THE OXYGENATOR, WITH THERAPY-ADEQUATE ACT. THE PROCEDURE WAS AN AORTOCORONARY BYPASS. THERE WAS NO SIGNIFICANT DELAY OF SURGERY. THE TREATMENT OF THE PATIENT WAS PERFORMED AS PLANNED. THE OXYGENATOR WAS EXCHANGED WITH AN FX15. PATIENT DATA: BSA: 1,72 M2. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT; POTENTIAL HARM DUE TO PRESSURE INCREASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11054597 ↗
• MalfunctionSep 5, 2019Break; Break

  THE USER FACILITY REPORTED THAT THERE WAS A PROBLEM WITH THE INVOLVED CAPIOX DEVICE. ONE OF THE RED PORT HAD A PROBLEM, THEY WERE CONCERNED THAT THERE WOULD BE PROBLEM DURING OPERATION, THIS PORT IS USED TO ADMINISTER THE DRUGS. THE EVENT OCCURRED PRE-TREATMENT; THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: No Information

  MAUDE report 8964738 ↗
• MalfunctionJul 5, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED OXYGENATOR CX*FX15RW30 WAS LEAKING DURING USE; IT WAS FOUND DURING PRIMING; BLOOD LOST WAS NOT RELATED TO THE REPORTED EVENT. THE ACTUAL SAMPLE WAS CHANGED OUT. THE EVENT OCCURRED PRE-TREATMENT; THERE WAS NO PATIENT INVOLVEMENT, THE PATIENT OUTCOME AND PATIENT CONDITION WAS NOT AVAILABLE.

  Patient problems: No Information

  MAUDE report 8763914 ↗
• MalfunctionApr 25, 2017Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED INSUFFICIENT GAS EXCHANGE IN THE CAPIOX DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION; THE TERUMO OXYGENATOR WAS NOT PART OF THE TERUMO TUBING PACK; THE OXYGENATOR WAS CHANGED OUT; NO BLOOD LOSS DURING THE OXYGENATOR CHANGE OUT; THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE; AND THE PATIENT WAS TREATED AS INTENDED WITH NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6517920 ↗
• InjurySep 22, 2016Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED A PRESSURE INCREASE WHEN USING THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: PERFUSION STARTED AT 10:36 WITH A DELTA P ABOUT 120MMHG; PRESSURE CONTINUOUSLY INCREASED UP TO 420MMHG AT 11:00; IT WAS REPORTED THAT THE COMPLETE MACHINE WAS EXCHANGED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5971387 ↗
• InjuryApr 27, 2016Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED INSUFFICIENT GAS EXCHANGE IN THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AFTER STARTING THE HLM (EKZ) AND AN ACT 620 SECONDS IN NORMOTHERMIA, CONTINUOUS DELTA-P INCREASE TO 680MM/HG WITHIN MINUTES; THE PATIENT WAS REMOVED FROM HLM; THE SYSTEM WAS CHANGED OUT TO A SORIN EVOLUTION; THERE WAS NO INCREASE OF DELTA-P; THE SURGERY WAS COMPLETED; THE AMOUNT OF BLOOD LOSS WAS UNKNOWN; AND THE PATIENT WAS REPORTED AS DOING GOOD.

  Patient problems: Blood Loss

  MAUDE report 5612372 ↗