CAPIOX®FX CX*FX05RERecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04987350781758), received between Apr 27, 2016 and Jan 29, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Obstruction of Flow

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING PRIMING, THE ONE-WAY VALVE WAS FOUND TO BE BLOCKED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, THERE WAS NO PATIENT INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210178 ↗
• MalfunctionFeb 12, 2025Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THEY HAD A LEAKY VALVE IN THE FX05. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364511 ↗
• MalfunctionDec 3, 2024Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE BLOOD INLET WAS DEFORMED. 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 20830970 ↗
• InjuryJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE THEY PRIMED WITH NO PROBLEM, BUT WHEN USER STARTED TO FLASH CO2, THE USER FOUND BLOOD LEAKAGE FROM THE SIDE OF FX05 OXYGENATOR BLOOD OUTLET AND GAS OUTLET. CHANGE NEW FX05 OXYGENATOR IMMEDIATELY.THE OXYGENATOR WAS CHANGED OUT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666297 ↗
• MalfunctionJul 6, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE CAPIOX OXYGENATOR WAS DAMAGED B.U. TEMPERATURE PROBES ON FX05 WERE BROKEN. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263983 ↗
• MalfunctionApr 28, 2023Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT THE CAPIOX OXYGENATOR INVOLVED HAD LOW OXYGENATION, THE COSTUMER VERIFIED ALL CONNECTIONS, AND ALL WAS FINE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. NO HEALTH HAZARDS WERE REPORTED AT THE TIME THE INFORMATION WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831489 ↗
• InjuryJun 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT FIRST THEY DID BYPASS FOR 75 MIN. THEN THE PATIENT WAS SMOOTHLY OFF AFTER THE ECHO WAS DONE. PROTEMEN WAS GIVEN TO THE PATIENT AT THAT TIME OUT ALL PUMP SUCKERS WAS OFF. AFTER A FEW MINUTES, THE PATIENT HAD SOME PROBLEM AGAIN, SO THEY GAVE THEM HEPARIN AND INITIATED BYPASS THE PATIENT. SECOND TIME WE FOUND PROBLEM IN OXYGENATOR AND THE OXYGENATION DID NOT OCCUR AND THEY REPLACED WITH NEW ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828303 ↗
• MalfunctionJan 11, 2022Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  THE USER FACILITY REPORTED SMALL RED CLOTS THAT WAS VISIBLE ON THE SIDE OF THE OXYGENATOR MEMBRANE. THE EVENT OCCURRED DURING CARDIOPULMONARY BYPASS, THERE WAS NO DELAY IN THE PROCEDURE, THE PRODUCT WAS NOT CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT EFFECT. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13224830 ↗
• MalfunctionDec 13, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT. THE CONNECTOR OF SAMPLE LINE COULD NOT BE FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982670 ↗
• MalfunctionAug 10, 2021Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED AN AIR BUBBLE ON THE CAPIOX DEVICE OXYGENATOR DURING CARDIOPULMONARY BYPASS. THERE WAS NO DELAY WITH BEGINNING OR CONTINUING THE PROCEDURE; THE PRODUCT WAS CHANGED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM TO THE PATIENT. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299779 ↗
• MalfunctionSep 18, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THE INVOLVED CAPIOX RESERVOIR LEAKED BEFORE BYPASS, DURING PRIME. THEY FEEL THAT THE ISSUE IS THAT THE RESERVOIR OUTLET CURVES A BIT, THEY HAD THOUGHT THEY PERHAPS DID IT DURING SET UP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCT WAS CHANGED OUT. THERE WAS NO BLOOD LOSS AS A RESULT OF THE ISSUE. THE PROCEDURE WAS NOT DELAYED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10553924 ↗
• MalfunctionSep 18, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THE INVOLVED CAPIOX RESERVOIR LEAKED BEFORE BYPASS, DURING PRIME. THEY FEEL THAT THE ISSUE IS THAT THE RESERVOIR OUTLET CURVES A BIT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCT WAS CHANGED OUT. THERE WAS NO BLOOD LOSS AS A RESULT OF THE ISSUE. THE PROCEDURE WAS NOT DELAYED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10553912 ↗
• MalfunctionJul 10, 2020Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED DURING THE PROCEDURE. THE PATIENT WAS A VICTIM OF AN ANESTHETIC ACCIDENT (GAS EMBOLISM) DURING HEART SURGERY, AND SHE HAS SINCE SUFFERED SERIOUS NEUROLOGICAL AFTER-EFFECTS. THE EXTRACORPOREAL CIRCULATION CIRCUIT (ARTIFICIAL RESPIRATOR) WOULD BE IMPLICATED; HIS EQUIPMENT CONSISTS OF A PUMP (BY LIVANOVA) AND A CIRCUIT (TERUMO). THE PERFUSIONIST OF THIS HOSPITAL REPORTED THAT THEY DID NOT REPORT THIS EVENT AT THE TIME OF THE EVENT, THEY MENTIONED THAT THE DEVICE WAS NOT DEFECTIVE, A HUMAN ERROR HAS OCCURRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS HARMED.

  Patient problems: Air Embolism

  MAUDE report 10256600 ↗
• InjuryApr 29, 2020Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE AND THERE WAS A PROBLEM ASSOCIATED WITH THE UNINTENDED ESCAPE OF A GAS FROM THE CONTAINER IN WHICH IT IS HOUSED. ON BYPASS TWO AIR BUBBLES WENT UP THE ARTERIAL LINE, WHICH ACTIVATED THE BUBBLE SENSOR AND REMOVED VIA THE CANNULA. THEY CALLED A SECOND PERFUSIONIST AND THEY DECIDED TO WEEN THE PATIENT FROM BYPASS AND CIRCULATE THROUGH THE CIRCUIT. NO AIR BUBBLES COULD BE SEEN; HOWEVER, THEY SWITCHED OUT THE OXYGENATOR. AFTER THE CASE WAS SUCCESSFULLY COMPLETED, THEY REINTRODUCED INITIAL OXYGENATOR TO TRY AND RE -ENACT BUBBLES HOWEVER, NOTHING WAS FOUND. THERE WAS POTENTIAL HARM DUE TO INTERRUPTION OF PROCEDURE AND USAGE STOP OF OXYGENATOR. THERE WAS NO ACTUAL HARM CAUSED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10008763 ↗
• MalfunctionDec 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE USER FACILITY REPORTED THAT THERE WAS A CUT/HOLE ON THE TUBING OF THE SAMPLE PORT OF CAPIOX OXYGENATOR. THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9509644 ↗
• InjuryNov 30, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT DURING CARDIOPULMONARY BYPASS, THE TARGET FLOW OF THE INVOLVED CAPIOX OXYGENATOR WAS 1L/MIN, HOWEVER, THEY COULD NOT GET THE FLOW ABOVE 300-400ML. THE EVENT DID RESULT IN ABOUT A 3-MINUTE DELAY IN BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE PRODUCT WAS CHANGED OUT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS 35ML OF BLOOD LOSS AS A RESULT OF THE REPORTED EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 14, 2018. THE USER FACILITY DOES NOT THINK THERE WAS A PROBLEM WITH THE OXYGENATOR. THE PATIENT'S FLOW REQUIREMENT WAS 1.0 LPM AND THEY HAD DIFFICULTY REACHING THE REQUIRED FLOW RATE AT THE INITIATION OF BYPASS (WAS ONLY ABLE TO FLOW ~400 ML/MIN) AND HAD A HIGH LINE PRESSURE. THE PERFUSIONIST NOTIFIED THE SURGEON, THEY CAME OFF BYPASS AND THE SURGEON RE-POSITIONED THE ARTERIAL CANNULA WHICH RESULTED IN THE ABILITY TO FLOW A LITTLE HIGHER BUT STILL HAD A HIGH LINE PRESSURE. THE PERFUSIONIST CLAMPED THE ARTERIAL LINE AT THE OUTLET OF THE OXYGENATOR, AND TRIED FLOWING THROUGH THE RECIRCULATION LINE AND WAS ABLE TO FLOW AT LEAST 800 ML/MIN THROUGH THE OXYGENATOR AND THE RECIRCULATION LINE. THE SURGEON RE-POSITIONED THE CANNULA TWICE

  Patient problems: Blood Loss

  MAUDE report 8119499 ↗
• MalfunctionFeb 7, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THERE WAS LEAK FROM THE RESERVOIR. DURING PRIMING THEY NOTICED A LEAK COMING FROM THE OUTLET OF THE RESERVOIR. THERE IS A CLEAR BEND IN THE MOLD OF THE OUTLET. THE EVENT DID NOT DELAY THE SURGICAL PROCEDURE. THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246966 ↗
• MalfunctionSep 11, 2017Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion; Device Operates Differently Than Expected

  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: FAILURE OF THE OXYGENATOR TO OXYGENATE THE BLOOD AT 21°C OF THE PATIENT'S NASOPHARYNGEAL TEMPERATURE; SUDDEN DROP IN PAO2 AND ARTERIAL SATURATION VALUES THROUGH THE CDI 500 MONITORING, AS EVIDENCED BY ARTERIAL GASOMETRY ANALYSIS; DUE TO THE FIRST ERROR, THERE WAS A NEED TO IMPLEMENT THE PROTOCOL OF CEREBRAL PROTECTION (PHARMACOLOGICAL AND DEEP HYPOTHERMIA); ELECTIVE PEDIATRIC SURGERY TO CLOSE CIA + CIV + DEBANDING AP, CEC MACHINE - TERUMO SYSTEM 1, GAS MONITORING ONLINE - CDI 500, DUAL - SIZE TUBES: 1/4 "- VENOUS BLOOD INLET, 3/16 "- VENOUS BLOOD OUTFLOW, 1/4 "- 3/16" - ARTERIAL PUMP, (B)(6) 2016 "- ARTERIAL BLOOD OUTLET. CHECKING THE PRE-BYPASS CHECK LIST (SERVICE ROUTINE); PREPARATION OF PRIMING (CALCULATION ACCORDING TO THE PEDIATRIC PROTOCOL OF THE SERVICE), AND ITS CIRCULATION: O SODIUM BICARBONATE, O MANNITOL 20%, OR HEPARIN, THE FRESH PLASMA, THE PLASMA LYTE; ADMINISTERED HEPARIN AND ITS CONTROL, ACT = 434 SEC. ENTERING INTO ECC: ARTERIAL CANNULA = 12 FR AND VENOUS: VCS = 12 FR AND VCI = 16 FR. VENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856590 ↗
• MalfunctionSep 11, 2017Complete Blockage; Complete Blockage; Device Inoperable; Defective Device

  THE USER FACILITY REPORTED A FAILURE WITH THE CAPIOX DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A TERUMO BABY FX OXYGENATOR FAILURE 5 MINUTES AFTER EXTRACORPOREAL CIRCULATION (ECC), WITH BLOCKAGE / OCCLUSION / COLLAPSE OF ARTERIAL OXYGENATOR OUTPUT; AT FULL ECC DURING PATIENT COOLING FROM 37 °C TO 32°C (WATER FROM THE COOLING / HEATING UNIT CIRCULATING AT 30°C), TOTAL VENOUS DRAINAGE OBSERVED WITHOUT ANY OXYGENATED BLOOD FLOW FROM THE OXYGEN; COMPLETE IMPOSSIBILITY OF RETURNING OXYGENATED BLOOD TO THE PATIENT WAS OBSERVED; ACT (+/- 10 MINUTES BEFORE THE EVENT) = 434 SEC.; ELECTIVE PEDIATRIC SURGERY TO CLOSE CIA + CIV + DEBANDING AP, CEC MACHINE - TERUMO SYSTEM 1, GAS MONITORING ONLINE - CDI 500, DUAL - SIZE TUBES: 1/4 "- VENOUS BLOOD INLET, 3/16 "- VENOUS BLOOD OUTFLOW, 1/4 "- 3/16" - ARTERIAL PUMP, (B)(6) 2016 "- ARTERIAL BLOOD OUTLET; CHECKING THE PRE-BYPASS CHECK LIST (SERVICE ROUTINE); PREPARATION OF PRIMING (CALCULATION ACCORDING TO THE PEDIATRIC PROTOCOL OF THE SERVICE), AND ITS CIRCULATION: O SODIUM BICARBONATE, O MANNITOL 20%, OR HEPARIN, THE FRESH PLASMA, THE PLASMA LYTE; ADMINISTERED HEPARIN AND ITS CONTR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856505 ↗
• MalfunctionMay 8, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAK IN THE CAPIOX DEVICE DURING PRIMING. FOLLOW UP COMMUNICATION WITH THE USER FACILITY PROVIDED THE FOLLOWING INFORMATION: (1) A LEAK OF PRIMING SOLUTION WAS NOTED AT THE ARTERIAL BLOOD EXIT OF THE OXYGENATOR; (2) AFTER INSPECTION, A CRACK WAS FOUND IN THE ARTERIAL BLOOD EXIT; (3) THE OXYGENATOR WAS TAKEN FROM THE BOX, THERE WERE NO SIGNS OF DAMAGE ON THE OXYGENATOR BOX; AND (4) THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6552426 ↗
• MalfunctionOct 25, 2016Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED INSUFFICIENT GAS-EXCHANGE IN THE FX05 CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: IN THE FIRST FIVE MINUTES OF CARDIOPULMONARY BYPASS, PRIOR TO THE INITIAL DOSE OF CARDIOPLEGIA, THE PAO2 DROPPED TO LESS THAN 100 MMHG AND THE PACO2 INCREASED AND THIS OCCURRED RIGHT AFTER THE HLM (SYSTEM-1) WAS MOVED BACK FROM THE OPERATING ROOM TABLE IN ORDER TO ALLOW ACCESS TO A SURGEON; IT WAS REPORTED THAT FIO2 AND GAS FLOW INCREASES IMPROVED BLOOD GAS VALUES; IT WAS REPORTED THAT THERE WERE NO OTHER ISSUES THE REMAINDER OF THE PROCEDURE; THE PRODUCT WAS NOT CHANGED OUT; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO IMPACT TO THE PATIENT. A CONVERSATION BETWEEN CLINICAL AND THE PERFUSIONIST WAS REPORTED AS FOLLOWS: THE CASE WAS A VSD CLOSURE ON A (B)64) FEMALE PATIENT THAT WEIGHED (B)(6). AN FX05 OXYGENATOR WAS USED, AS WAS THE CDI 500 BLOOD PARAMETER MONITOR. IN ORDER TO REDUCE TUBING LENGTHS (AND PRIME VOLUME) OF THE CPB CIRCUIT, THE SYSTEM-1 HLM IS POSITIONED VERY CLOSE TO THE PATIENT. IN THE FIRST 5 MINUTES OF CPB THE SYSTEM-1 WAS BRIEFLY MOVED AWAY FROM THE SURGICAL TABLE TO ALLOW A CV SURGEON TO GAI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6053838 ↗
• MalfunctionOct 18, 2016Excessive Cooling; Temperature Problem; Excessive Cooling; Temperature Problem

  THE USER FACILITY REPORTED AN ISSUE WITH THE ACCURACY OF THE VENOUS TEMPERATURE MEASUREMENT DURING CARDIOPULMONARY BYPASS. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: WHEN WEANING FROM CPB, THE VENOUS INLET TEMPERATURE MEASUREMENT DROPS UP TO 2 DEGREES C FROM PRE-WEAN FULL FLOW TEMPERATURE MEASUREMENT; THE PRODUCT WAS NOT CHANGED OUT; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND IT WAS REPORTED THERE WERE NO PATIENT ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6036173 ↗
• MalfunctionApr 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: PAO2 WAS LOWER THAN EXPECTED AND PACO2 WAS HIGHER THAN EXPECTED IN THE FIRST 10 MINUTES OF CARDIOPULMONARY BYPASS; IT WAS REPORTED THAT THE PRODUCT WAS NOT CHANGED OUT; SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5611503 ↗