CAPIOX®FX CX*FX05RWRecalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 04987350781772), received between Jul 26, 2016 and Feb 10, 2026 — classified as 13 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (22 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 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Material Deformation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE OXYGENATOR'S BLOOD OUTLET HAD DEFORMATION. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303564 ↗
• MalfunctionFeb 6, 2026Leak/Splash

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING PRIMING WITH BLOOD, BLOODY FLUID WAS FOUND FLOWING FROM THE GAS OUTLET PORT. THERE WAS NO PATIENT INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24285260 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING CARDIOPULMONARY BYPASS (CPB), BLOODY FLUID LEAKED FROM THE GAS OUTLET PORT. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233835 ↗
• InjuryNov 20, 2025Gas Output Problem; Gas Output Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. AT INITIATION OF CARDIOPULMONARY BYPASS BLOOD FLOW WAS 0.5 LPM, SWEEP FLOW 0.35 LPM FIO2 60%. INITIAL BLOOD GAS AFTER 5 MINUTES PO2 WAS 50 MMHG, PCO2 57 MMHG, SAO2 87%, HB 100 G/L, PATIENT NASAL TEMPERATURE 34.9 C. GAS LINE CONNECTION AND OXYGENATOR GAS EXHAUST WERE CHECKED. THE DECISION WAS MADE TO INCREASE FIO2 TO 95% AND SWEEP TO 1 LPM, REPEATED BLOOD GAS AFTER 5 MINUTES PO2 114 MMHG, PCO2 70 MMHG, SAO2 98% HB 93 G/L. DECISION MADE TO INCREASE FIO2 TO 95% AND SWEEP TO 1.5 LPM. REPEATED BLOOD GAS AFTER 4 MINUTES: PO2 489 MMHG, PCO2 74 MMHG, SAO2 100%, HB 96 G/L, PATIENT NASAL TEMPERATURE 34.5 C. THE SURGEON WAS INFORMED OF THE CO2 CLEARANCE ISSUE AND THE DECISION MADE TO CHANGE OUT THE OXYGENATOR. THE OXYGENATOR WAS REPLACED AND THE PATIENT RECOVERED WITHOUT FOLLOW-UP TREATMENT. THE FINAL PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609437 ↗
• InjuryAug 3, 2025Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED POOR OXYGENATION DURING CARDIOPULMONARY BYPASS (CPD). THE OXYGENATOR WAS CHANGED OUT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22696658 ↗
• MalfunctionJun 11, 2025Failure to Disconnect; Failure to Disconnect

  THE USER FACILITY REPORTED THAT IN THE PROCESS OF ASSEMBLY OF THE EXTRACORPOREAL CIRCULATION CIRCUIT IN A STERILE WAY, THE OPERATOR ATTEMPTED TO DISCONNECT AN EXTENSION PRESENT IN THE UPPER PART OF THE OXYGENATOR, HOWEVER, THE PART WAS STUCK, WHICH MADE IT IMPOSSIBLE TO DISCONNECT AND MOVE THE EXTENSION TO ANOTHER PART OF THE MEMBRANE OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191412 ↗
• MalfunctionJun 6, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT A LEAKAGE OCCURRED. WHILE PRIMING THE OXYGENATOR, MULTIPLE BUBBLES WERE OBSERVED COMING FROM THE VENOUS FILTER, SPECIFICALLY AT THE BOTTOM. THE OXYGENATOR WAS IMMEDIATELY REPLACED WITH A NEW CAPIOX FX05. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED. THE PROCEDURE OUTCOME WAS NOT REPORTED, AND NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158708 ↗
• MalfunctionMay 22, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER FACILITY REPORTED THAT THE INLET PORT OF THE OXYGENATOR WAS FOUND TO BE LOOSE DURING THE DEVICE PREFILLING PROCESS. THE EVENT OCCURRED BEFORE TREATMENT, WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072598 ↗
• MalfunctionMay 8, 2025Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB), PCO2 NORMAL, PCO2 HIGHER THAN NORMAL. THE VENTILATION IS 3L/MIN. BEFORE CPB, THE PCO2 WAS 46.2 MMHG; DURING CPB, PCO2 WAS MEASURED 3 TIMES, WITH VALUES OF 59.8 MMHG, 73.9 MMHG, AND 56.6 MMHG, RESPECTIVELY; AFTER CPB, THE PCO2 WAS 48.9 MMHG. THE CUSTOMER REPORTED THAT 17 CX*FX05RW OXYGENATORS HAVE BEEN USED BY THEM, AND ONLY ONE EVENT OCCURRED ABOUT OXYGENATOR HAS SHOWN ABNORMAL PCO2. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987866 ↗
• MalfunctionJan 7, 2025Lack of Effect; Lack of Effect

  THE USER REPORTED THAT AIR BUBBLES KEEP FORMING ON THE FX05, INDICATING A PROBLEM WITH THE MEMBRANE. THE MEMBRANE SHOULD BE CHECKED FOR LEAKS BECAUSE AIR CAN PENETRATE THE OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098851 ↗
• MalfunctionDec 12, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT LEAKAGE AT THE OUTLET OF THE OXYGENATOR OCCURRED DURING PRIMING. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913318 ↗
• MalfunctionNov 20, 2024Lack of Effect; Lack of Effect

  THE USER REPORTED THAT THEY HAD AN UNEXPLAINED OXYGENATOR DE-PRIME TODAY. THERE WAS NO HARM TO THE PATIENT. IT OCCURRED DURING POST-BYPASS ULTRAFILTRATION (MODIFIED ULTRAFILTRATION). THE PERFUSIONIST RE-PRIMED THE OXYGENATOR AND IT OCCURRED AGAIN. CAUSE UNKNOWN. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738081 ↗
• MalfunctionOct 15, 2024Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE BLOOD INLET PORT WAS DEFORMED/KINKED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452768 ↗
• MalfunctionSep 11, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE, THE PRIMING SOLUTION COULD NOT BE PUMPED INTO THE OXYGENATOR AND FILL THE CHAMBER, WHICH WERE FILLED WITH AMOUNTS OF BUBBLES. THEN A NEW DEVICE WAS REPLACED TO COMPLETE THE OPERATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189693 ↗
• InjuryJun 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED LEAKAGE WITH THE CAPIOX DEVICE INVOLVED. THE PROCEDURE WAS A REPAIR OF ATRIAL SEPTAL DEFECT (ASD). THIRTEEN (13) MINUTES AFTER THE CPB WAS RUNNING, BLOOD DRIPPED OUT OF GAS OUTLET. CPB BLOOD FLOW WAS 1.37L/MIN, THE VALUE OF GAS FLOW AND FIO2 ARE NOT OBTAINED. THE BLOOD GAS RESULTS WERE PCO2 61.7, PO2 108, PH 7.267. THE DEVICE WAS REPLACED WITH ANOTHER FX05, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467133 ↗
• MalfunctionMay 16, 2024Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED HIGH PRESSURE INVOLVING THE CAPIOX OXYGENATOR. THE PERFUSIONIST PRIMED THE OXYGENATOR AND CONNECTED IT TO THEIR INLINE GAS SENSORS. WHEN THE CONNECTION WAS TAKEN OFF THERE WAS A LOUD BANG AND THE PERFUSIONIST FELT QUITE A BIT OF PRESSURE. THEY CHANGED THE GAS TUBING AND CHANGED THE OXYGEN; HOWEVER, ANOTHER BANG WAS HEARD, AND PRESSURE WAS FELT. THEY THEN CHANGED OUT THE OXYGENATOR AND STARTED THE WHOLE PROCESS AGAIN. ON THE SECOND ATTEMPT WITH A NEW OXYGENATOR, THEY HAD NO ISSUES. AS A RESULT, THE START OF THE PROCEDURE WAS DELAYED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330091 ↗
• MalfunctionMay 14, 2024Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED LEAKAGE WITH THE CAPIOX DEVICE INVOLVED. DURING PRIMING, THE PERFUSIONIST FOUND A LOT OF BUBBLES IN GAS OUTLET AFTER HE ADDED BLOOD TO REPLACE CRYSTALLOID. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310208 ↗
• MalfunctionMar 8, 2024Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE NEONATAL MEMBRANE OXYGENATOR DEFORMED AT THE ARTERIAL ROLLER CONNECTION INLET, RENDERING THE PRODUCT UNUSABLE. THE EVENT WAS NOTICED DURING ASSEMBLY WITH THE PRESENCE OF A PROTECTIVE CAP. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864973 ↗
• MalfunctionFeb 6, 2024Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT LEAKAGE OF THE CAPIOX DEVICE WAS NOTICED BY THE PERFUSIONIST WHEN THEY STARTED THE PRIMING OF THE OXYGENATOR BEFORE THE START OF SURGERY. THE DEVICE WAS REPLACED WITH A FRESH ONE FROM STOCK AND THE SURGERY WAS NOT INTERRUPTED. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650080 ↗
• MalfunctionNov 27, 2023Break; Break

  THE USER FACILITY REPORTED BLOOD INLET PORT BREAKAGE. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208270 ↗
• MalfunctionNov 8, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE BLOOD INLET PORT ON THE CAPIOX FX05 APPEARED DEFORMATION. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091816 ↗
• MalfunctionJul 9, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED OXYGENATOR PRESENTS A LEAKAGE. EVERYTHING WAS ASSEMBLED, OXYGENATOR, LINES, HEAT EXCHANGER, THEN THE CO2 FLUSHED FOR 5 MINUTES. AT THE TIME OF RECIRCULATING THE PRIMING, A LEAK WAS NOTICED IN THE ARTERIAL OUTLET. THEREFORE, THE CONNECTOR WAS RETIGHTENED (REDUCER), HOWEVER IT KEPT LEAKING, THEN IT WAS CHANGED TO ANOTHER CONNECTOR, (THINKING IT WAS CRACKED) BUT THE SAME THING HAPPENED. FINALLY, CHANGED TO ANOTHER OXYGENATOR AND IT FUNCTIONED WITHOUT PROBLEMS. ALL THIS HAPPENED BEFORE THE CEC. THERE WAS AN UNKNOWN MINUTE OF DELAY IN BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM AND BLOOD LOSS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17284952 ↗
• MalfunctionMar 9, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TECHNICAL ISSUES IN A PROCEDURE FOR ATRIOVENTRICULAR (AV) CANAL DISEASE ON A CARDIOPULMONARY BYPASS MACHINE, AND DURING THE PRIMING WITH BLOOD BEFORE THE SURGERY AS A ROUTINE WE NOTE A DARK BLOOD IN THE PRIMING. THEY REPLACED THE OXYGENATOR IMMEDIATELY. THE GAS FLOW WAS TURNED ON AND THE GAS LINE WAS CONNECTED TO OXYGENATOR CORRECTLY. THE PRIMING COMPOSITION WAS NORMAL SALINE (NS)/RED BLOOD CELLS (RBC)/FRESH FROZEN PLASMA (FFP). A BLOOD GAS WAS PERFORMED. THE PO2 OF THE BLOOD WAS ANALYZED TO VALIDATE AND WAS PO2 30%. THE PERFUSIONIST PUT THE OXYGENATOR ON HEPARIN FORMULA. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED. IT IS UNKNOWN IF THERE WERE ANY OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513599 ↗
• InjuryDec 16, 2022Leak/Splash; Increase in Pressure; Leak/Splash; Increase in Pressure

  THE USER FACILITY REPORTED THAT THE CAPIOX OXYGENATOR PORT WAS LEAKING. DRIPPING LEAKAGE AT THE GAS OUTLET WAS DETECTED DURING PRIMING. THE OXYGENATOR WAS EXCHANGED WITH AN IDENTICAL OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED. THE PRODUCT MALFUNCTIONED DUE TO LEAKAGE. THIS IS CONSIDERED SERIOUS AS THE PRODUCT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996355 ↗
• InjuryDec 5, 2022Break; Increase in Pressure; Break; Increase in Pressure

  THE USER FACILITY REPORTED THAT WHEN THE CAIPOX DEVICE OXYGENATION, WAS HIGH PRESSURED. OVERPRESSURE OF THE OXYGENATOR WAS HYPOTHESIZED WITH A POSSIBLE BREAKAGE OF OXYGENATING FIBER THAT HAS DETERMINED GASEOUS EMBOLISM ALONG THE ARTERIAL LINE OF THE CEC CIRCUIT. THERE WERE NO CONSEQUENCES AND WAS A REGULAR POST OPERATIVE COURSE. THE PROBLEM OCCURRED DURING A CARDIO BYPASS BEFORE X-CLAMPS. THE EVENT RESULTED IN A 20-MINUTE DELAY. THE PRODUCT WAS CHANGED OUT, CAPIOX FX05.NO CONSEQUENCES FOR THE PATIENT. AS A RESULT OF THE REPORTED ISSUE 380ML OF BLOOD WAS LOST. FLOW WAS 650ML/MINUTES AND PRESSURE OUT WERE 600MMHG. THE EVENT OCCURRED INTRA-OPERATIVE. THE DEVICE MALFUNCTION DUE TO INCREASING PRESSURE. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921016 ↗