Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX25RECRecalls & reported problems

Summary

The FDA's MAUDE database contains 267 adverse event reports that list this exact device (DI 00699753450820), received between Apr 28, 2016 and Jan 13, 2026 — classified as 3 deaths, 17 injuries, 247 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 267 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR LEAKED AT THE OUTLET PORT, BONE WAX WAS USED TO STOP THE LEAK AND PROCEED WITH THE CASE. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH 2-3 ML BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051336 ↗
• InjuryDec 23, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR FAILED. THE ISSUE WAS MITIGATED, INITIALLY, BY ADDING A SECOND OXYGENATOR TO THE SYSTEM, BUT THAT DID NOT RESULT IN STABLE PARTIAL PRESSURE OF OXYGEN, SO AN ENTIRE OXYGENATOR/RESERVOIR/CARDIOPLEGIA/HEART PACK WERE PRIMED AND BROUGHT INTO THE OPERATING ROOM. THERE WAS APPROXIMATELY 500 ML OF BLOOD LOST IN SWITCHING OUT THE ENTIRE PUMP SYSTEM WHEN ADDING 2ND OXYGENATOR DID NOT SOLVE THE ISSUE. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH 52 MINUTES DELAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23876900 ↗
• MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A CARBON DIOXIDE (CO2) REMOVAL ISSUE. OTHER SOURCES WERE CHECKED THAT COULD CAUSE ELEVATED PCO2 ON BYPASS AND ALL OTHER DEVICES ARE WITHIN NORMAL LIMITS. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720823 ↗
• MalfunctionSep 11, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE FX25 APPEARED NOT TO OXYGENATE UPON REWARMING. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033720 ↗
• InjuryAug 21, 2025Defective Device; Defective Device

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST BASED ON THE PUMP RECORD REVEALED THAT, THE PATIENT WAS 175CM TALL, WEIGHT OF 94KG AND BSA OF 2.1M2. THE PERFUSIONIST ADMINISTERED 10,000 INTERNATIONAL UNITS (IU) OF HEPARIN INTO THE PUMP PRIME. ANESTHESIOLOGIST GAVE 30,000 IU HEPARIN AT 10:30AM TO THE PATIENT, RESULTING IN AN ACTIVATED CLOTTING TIME (ACT) OF 348 SECONDS, BELOW OPTIMAL VALUE FOR BYPASS INITIATION. ANESTHESIOLOGIST THEN GAVE AN ADDITIONAL 10,000 IU HEPARIN AT 10:45AM TO THE PATIENT. THE PERFUSIONIST WENT ON BYPASS AT 10:49AM WITH AN UNKNOWN ACT VALUE. WITHIN MINUTES, THE PERFUSIONIST NOTICED A DARK RED COLORATION IN THE ARTERIAL TUBING AND ASSUMED OXYGEN FAILURE AND NOTIFIED THE SURGEON AND ANESTHESIOLOGIST. THE ANESTHESIOLOGIST IMMEDIATELY STARTED VENTILATING THE LUNGS. THE OXYGENATOR WAS CONNECTED DIRECTLY TO AN OXYGEN TANK FOR GAS SOURCE. THE OXYGENATION APPARENTLY DID NOT IMPROVE. THE BYPASS WAS STOPPED AT 10:54AM. THE PERFUSIONIST GAVE AN ADDITIONAL 20,000 IU HEPARIN INTO THE OXYGENATOR AND THE PATIENT WAS PLACED BACK ON BYPASS AT 10:55AM. AT 11:15AM THE ACT VALUE WAS 483 SECONDS, AND THE PARTIAL PRESSURE OF OXYGEN (PO2) WAS 475MMHG WITH A FRACTION OF INSPIRED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22867760 ↗
• MalfunctionJul 18, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE CONNECTION BETWEEN THE TUBE AND THE WHITE CONNECTOR WAS FAULTY, RESULTING IN A LEAK. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT; IT WAS SEALED; THE PROCESS WAS THEREBY COMPLETED. IT IS UNKNOWN IF THERE WAS A BLOOD LOSS. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541820 ↗
• MalfunctionJul 10, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRE-CARDIOPULMONARY BYPASS, THERE WAS A POSSIBLE HEAT EXCHANGER LEAK. AS PER USER FACILITY, THE ARTERIAL/VENOUS LINES CLAMPED, SHUNTS AND RECIRC LINES CLAMPED. S5 HEART LUNG MACHINE (HLM) WITH CENTRIFUGAL AND MYOCARDIAL PROTECTION SYSTEM (MPS) CARDIOPLEGIA SYSTEM. PERFUSIONIST COULD NOT FIGURE OUT WHERE VOLUME WAS GOING. REQUIRED CHANGE OF CIRCUIT AND HEART LUNG MACHINE (HLM) TO CONTINUE THE CASE. INQUIRED ABOUT POSSIBLE HEAT EXCHANGER LEAK OR OTHER MALFUNCTIONS THAT COULD ALLOW VOLUME TO "DISAPPEAR" FROM THE RESERVOIR AND CIRCUIT. NO VOLUME NOTED ON THE FLOOR. PRODUCT WAS CHANGED OUT, THERE WAS A 30 MINUTE DELAY, THERE WAS A MINIMAL BLOOD LOSS ESTIMATING OF LESS THAN 100 ML, PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470572 ↗
• MalfunctionJun 26, 2025Obstruction of Flow; Obstruction of Flow

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE POLYESTER FILTER IN THE VENOUS RESERVOIR DIDN¿T ALLOW THE TRANSIT OF BLOOD COMING FROM SUCKERS AND VENT. AS PER THE SUBSIDIARY, AFTER USAGE FOR 296 MINUTES OF CAPIOX FX25 ADVANCE OXYGENATOR IN CARDIOPULMONARY BYPASS DURING AN INTERVENTION OF AORTIC DISSECTION TYPE A, REPLACEMENT OF THE DEVICE BECAME NECESSARY BECAUSE THE POLYESTER FILTER IN THE VENOUS RESERVOIR DIDN¿T ALLOW THE TRANSIT OF BLOOD COMING FROM SUCKERS AND VENT AND IT WAS NOT POSSIBLE TO GIVE ANY KIND OF FLUID TO THE PATIENT THROUGH THE PORTS ON THE RESERVOIR. ALL THESE PROBLEMS MADE IMPOSSIBLE GO ON WITH BYPASS. IN ACCORDANCE WITH CARDIAC ANESTHETIST, THE REPLACEMENT OF OXYGENATOR HAS BEEN MADE; THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITH A DURATION OF CHANGE FOR 3 MINUTES AND THEN WAS STARTED AGAIN TO END THE SURGERY. PRODUCT WAS CHANGED OUT. THERE WAS A 3 MINUTE MORE OR LESS DELAY IN THE BEGINNING OF THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342378 ↗
• MalfunctionJun 10, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE OXYGENATOR WAS LEAKING. NO PATIENT INVOLVEMENT THE PRODUCT WAS CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175603 ↗
• MalfunctionMay 9, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR'S OXYGENATION AND DECARBOXYLATION PERFORMANCE MASSIVELY DECREASED. AS PER USER FACILITY, AT 12:33 BGA (ARTERIAL BLOOD GAS ANALYSIS) AT 100% O2 (THE OXYGEN SATURATION OF THE BLOOD), AND 10 L/MIN GAS FLOW. PO2: 7,54KPA (PO2 = THE PARTIAL PRESSURE OF OXYGEN, KPA = KILOPACALS). PCO2: 6,56KPA (PCO2 = THE PARTIAL PRESSURE OF CARBON DIOXIDE) FOLLOWING IMMEDIATE ACTION TAKEN: - FIO2: 100%; GAS FLOW: 10 L/MIN. (FIO2 = FRACTION OF INSPIRED OXYGEN). NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997573 ↗
• MalfunctionMar 6, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR DID NOT OXYGENATE. IT IS UNKNOWN IF THE PRODUCT WAS CHANGED OUT, IF THE SURGERY WAS COMPLETED, WHETHER THERE WAS A DELAY IN THE PROCEDURE, AND IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 21541002 ↗
• MalfunctionMar 6, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR DID NOT OXYGENATE. IT IS UNKNOWN IF THE PRODUCT WAS CHANGED OUT, IF THE SURGERY WAS COMPLETED, WHETHER THERE WAS A DELAY IN THE PROCEDURE, AND IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 21540807 ↗
• MalfunctionFeb 21, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, A LEAKAGE WAS NOTICED. THERE WAS A LITTLE BLOOD COMING OUT OF THE OXYGENATOR. A SMALL LEAK BUT NO HARM TO THE PATIENT. THERE WAS NO CHANGE IN BLOOD GAS SAMPLES. THEY WERE NOT ABLE TO KEEP THE OXYGENATOR AND SEND IT BACK. THEY DISPOSED OF IT BY ACCIDENT. NO HEALTH CONSEQUENCES OR IMPACT; PRODUCT WAS NOT CHANGED OUT; PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435673 ↗
• MalfunctionFeb 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRE- CARDIOPULMONARY BYPASS, THE RESERVOIR LEVEL WAS DROPPING WITHOUT ANY OPEN SHUNTS OR EXTERNAL LEAKS. PROCEDURE DELAYED BY LESS THAN 15 MINUTES AS THEY WERE TROUBLESHOOTING AND SWAPPING OUT THE OXYGENATOR. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349786 ↗
• MalfunctionJan 31, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THERE WAS A 3 MINUTES DELAY IN BEGINNING OR CONTINUING THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284357 ↗
• MalfunctionNov 18, 2024Pressure Problem; Pressure Problem

  NEW INFORMATION RECEIVED; THERE WAS NO DELAY, THE PRODUCT WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT EFFECT AND NO BLOOD LOSS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711301 ↗
• MalfunctionJul 19, 2024Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE PRESSURE VALUE (DELTA P) OF OXYGENATOR HAS INCREASED. AS PER THE USER FACILITY, AT THE BEGINNING OF THE PROCEDURE, WHEN THE (HEART LUNG MACHINE) HLM WAS STARTED, THE ACTIVATED CLOTTING TIME (ACT) WAS OVER 500. AFTER THE HLM STARTED UP, THE ACT DROPPED TO 475. (B)(4) UNITS OF AT WERE ADMINISTERED AND (B)(4) UNITS OF HEPARIN. THE PRESSURE IN THE OXYGENATOR WAS SIGNIFICANTLY ABOVE THE TARGET VALUE. SINCE THERE IS THEN A RISK THAT THE OXYGEN WILL CLOSE, IT WAS REPLACED. THERE WAS NO SIGNIFICANT BLOOD LOSS. NO SIGNIFICANT DELAY TO FINISH THE PROCEDURE SUCCESSFULLY. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT PRODUCT WAS CHANGED OUT PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785675 ↗
• MalfunctionApr 12, 2024Temperature Problem; Temperature Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS THERE WAS A TEMPERATURE PROBES ISSUE. AS PER THE SUBSIDIARY, THE TEMPERATURE BEING MEASURED IS CONSISTENTLY 5 DEGREES CELSIUS DIFFERENT THAN THE BLADDER TEMPERATURE AND THEIR CARDIOQUIP TEMPERATURE. BOTH THE BLADDER TEMPERATURE AND CARDIO QUIP TEMPERATURE APPEAR TO BE CONSISTENT WITH EACH OTHER. THE TEMPERATURE BEING MEASURED FROM CAPIOX OXYGENATORS WAS DRAMATICALLY DIFFERENT AND CONSISTENTLY 5 DEGREES OFF. LIVA NOVA INSPECTED THE S5 HEART LUNG AND TEMPERATURE MODULES AND THEY ARE REPORTEDLY REPORTING ACCURATELY. ADDITIONALLY, THE CAPIOX TEMPERATURE PROBES THAT ARE ATTACHED TO THE CP50 CARDIOPLEGIA SET WERE ACCURATE. AS A MITIGATION, THE USER FACILITY USED HEATER COOLER TEMPERATURE AND BLADDER TEMPERATURE TO DETERMINE BLOOD FLOW TEMPERATURE TO RESOLVE THE PROBLEM. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19098335 ↗
• MalfunctionApr 12, 2024Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE AIR DETECTED IN CAPIOX. AS PER THE USER FACILITY, INCIDENT OCCURRED ON BYPASS. AIR WAS REMOVED WITH SHORT DELAY IN PROCEDURE. NO BLOOD LOSS REPORTED. OXYGENATOR WAS SAVED AND FLUSHED OUT WITH WATER TO BE INSPECTED BY TERUMO. THERE WAS AN UNKNOWN MINUTES OF DELAY. PRODUCT WAS NOT CHANGED OUT . PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097842 ↗
• InjuryFeb 13, 2024Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR PRESENTED A HIGHER THAN NORMAL LINE PRESSURES, AND DARKER THAN NORMAL BLOOD DURING THE CASE. THERE WAS A BRIEF DELAY WHILE THE OXYGENATOR WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY THERE WAS A BLOOD LOSS OF LESS THAN 200 CC (CUBIC CENTIMETERS).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18696760 ↗
• MalfunctionFeb 7, 2024High Readings; High Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS THE OXYGENATOR HAD AN ELEVATED FRACTION OF INSPIRED OXYGEN (FIO2) RATE OF (80-90%). THE FIO2 WAS INCREASED AS MITIGATION. *NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT *PRODUCT WAS NOT CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658718 ↗
• MalfunctionFeb 7, 2024High Readings; High Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR HAD AN ELEVATED FRACTION OF INSPIRED OXYGEN (FIO2) RATE OF (80-90%). THE FIO2 WAS INCREASED AS MITIGATION. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT PRODUCT WAS NOT CHANGED OUT PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657456 ↗
• MalfunctionFeb 7, 2024High Readings; High Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR HAD AN ELEVATED FRACTION OF INSPIRED OXYGEN (FIO2) RATE OF (80-90%). THE FIO2 WAS INCREASED AS MITIGATION. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657446 ↗
• MalfunctionFeb 7, 2024High Readings; High Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR HAD AN ELEVATED FRACTION OF INSPIRED OXYGEN (FIO2) RATE OF (80-90%). THE FIO2 WAS INCREASED AS MITIGATION. NO KNOWN HEALTH CONSEQUENCES OR IMPACT TO PATIENT, PRODUCT WAS NOT CHANGED OUT, PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657441 ↗
• MalfunctionJan 5, 2024Particulates; Particulates

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR CARDIOPULMONARY BYPASS, DURING OTHER - NON CLINICAL ACTIVITY, UPON UNPACKING AND INSPECTION, PARTICULATE IN THE MATERIAL (HOUSING) WAS DETECTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456357 ↗