CAPIOX®FX CX*FX25ERecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04987350701060), received between Feb 24, 2016 and Mar 13, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Material Deformation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE BLOOD INLET WAS WARPED ON THE OXYGENATOR. THE EVENT OCCURRED DURING SETUP, AND THE EVENT RESULTED IN A FEW MINUTES DELAY TO CHANGE THE PRODUCT OUT, LESS THAN FIVE MINUTES. THE PRODUCT WAS CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591771 ↗
• MalfunctionMay 16, 2024Pumping Problem; Pumping Problem

  THE USER FACILITY REPORTED THAT DURING THE SURGERY, THE PCO2 ROSE STEADILY FOR REASONS THAT ARE AS YET UNEXPLAINED. THE GAS FLOW AT THE SECHRIST-GAS BLENDER WAS SET TO MAXIMUM. DESPITE APPROPRIATE COUNTER-REGULATION, THE ACB SURGERY PROCEEDED WITH A CONTINUOUS RISE IN CO2. THERE WAS NO INCREASE IN PRESSURE IN THE OXYGENATOR. IN THIS CASE, MALIGNANT HYPERTHERMIA WAS ASSUMED. ALL APPROPRIATE THERAPEUTIC MEASURES WERE INITIATED. HOWEVER, THERE WAS NO IMPROVEMENT UNTIL THE EXTRACORPOREAL CIRCULATION WAS STOPPED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333072 ↗
• InjuryMay 10, 2024Pumping Problem; Pumping Problem

  THE USER FACILITY REPORTED THAT DURING THE SURGERY, THE PCO2 ROSE STEADILY FOR REASONS THAT ARE YET UNEXPLAINED. THE GAS FLOW AT THE SECHRIST-GAS BLENDER WAS SET TO MAXIMUM. DESPITE APPROPRIATE COUNTER-REGULATION, THE ACB SURGERY PROCEEDED WITH A CONTINUOUS RISE IN CO2. THERE WAS NO INCREASE IN PRESSURE IN THE OXYGENATOR. THE GAS FILTER WAS EXCHANGED; HOWEVER, THERE WAS STILL NO INCREASE OF THE PRESSURE. FURTHERMORE, THERE WAS ALSO AN OXYGENATION PROBLEM. THE OXYGENATOR WAS IMMEDIATELY CONNECTED TO AN EXTERNAL OXYGEN SUPPLY AND THE EMERGENCY CHANGE WAS PREPARED IN PARALLEL. THE SITUATION IMPROVED SIGNIFICANTLY IMMEDIATELY AFTER THE OXYGENATOR WAS CHANGED. THE OXYGENATOR WAS CHANGED OUT DUE TO POOR GAS EXCHANGE PERFORMANCE. THERE WAS NO HARM TO THE PATIENT. THE EVENT RESULTS DID RESULT IN PATIENT INJURY AND MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286911 ↗
• MalfunctionDec 27, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  THE USER FACILITY REPORTED THAT THE CAIPOX DEVICE INVOLVED WAS DAMAGED. THE EVENT OCCURRED OUT OF THE BOX. THE EVENT DID NOT RESULT IN A DELAY IN THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399246 ↗
• MalfunctionNov 13, 2023Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED IRREGULAR OXYGENATION DURING CARDIOPULMONARY BYPASS USING THE FX OXYGENATOR INVOLVED. OXYGENATION WAS LOW FROM THE START. TOWARDS THE END OF THE RUN CLOTS ON THE OXYGENATOR WERE NOTICED. ACT'S WERE GREATER THAN A 1000 THE ENTIRE RUN. PLATELET COUNT ON BYPASS WAS 84, THE START WAS 200. WHEN BYPASS WAS STARTED, THE PO2 WAS ABOUT 120 AT A FI02 OF 80. COOLING WAS DONE RIGHT AWAY AS IT WAS A CIRC ARREST CASE. THE FI02 WENT TO 100 AND IT WAS OBSERVED TO GO UP TO 400. CROSS CLAMPING WAS DONE AND BROUGHT THE FI02 DOWN AND THE PO2 DROPPED VERY QUICKLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS AS A RESULT OF THE ISSUE. THE EVENT DID NOT RESULT IN DELAY IN BEGINNING OR CONTINUING THE PROCEDURE. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121159 ↗
• MalfunctionFeb 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING EMERGENCY CARDIOVASCULAR CARE (ECC) THAT THERE WAS PLASMA LEAKAGE AFTER THREE HOURS EMERGENCY CARDIOVASCULAR CARE (ECC). THE TOTAL EMERGENCY CARDIOVASCULAR CARE (ECC) WAS THREE AND A HALF HOURS. THERE WAS NO NEGATIVE PERFORMANCE IMPACT. THE SURGERY COULD BE FINISHED WITH THE SAME OXYGENATOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373046 ↗
• MalfunctionDec 15, 2022Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED HIGH PRESSURE WITH THE OXYGENATOR INVOLVED. HIGH DELTA P DURING THE PROCEDURE. THE OXYGENATOR WAS NOT EXCHANGED DUE TO THE PROGRESS OF THE PROCEDURE. THE PROCEDURE COULD BE FINISHED WITH THE COMPLAINED OXYGENATOR. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987052 ↗
• MalfunctionJul 29, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE OXYGENATOR DEVICE INVOLVED HAD A BROKEN OXYGENATOR PORT. THE EVENT OCCURRED WHEN OUT OF THE BOX DURING PRE-SET UP. THE PRODUCT WAS NOT USED AND WAS NOT EXCHANGED OUT. THE EVENT DID NOT DELAY THE BEGINNING OR CONTINUING OF THE SURGICAL PROCEDURE. THE PRODUCT MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128178 ↗
• InjuryMar 18, 2022Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT THE OXYGENATOR DEVICE INVOLVED HAD A LOW PO2 AND SAO2. THE EVENT OCCURRED DURING A CARDIOPULMONARY BYPASS. THE EVENT DID NOT DELAY THE BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE LOW PO2 AND SAO2 OCCURRED DESPITE BEING ON 100% FIO2 WITH ADEQUATE FLOWS AND ADEQUATE HGB. THE DEVICE WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCT MALFUNCTION DID NOT CONTRIBUTE TO ANY PATIENT INJURY. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13810009 ↗
• MalfunctionDec 16, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. DURING PERFUSION THERE WERE NOTICEABLE HIGH CO2 VALUES. AT THE END OF THE PERFUSION PO2 =136MMHG AT FIO2 = 90%. THE OXY WAS NOT PART OF THE TERUMO TUBING PACK SET. NO SIGNIFICANT DELAY OF SURGERY. THE PATIENTS' TREATMENT WAS PERFORMED AS PLANED AND FINALIZED. THE OXY WAS NOT REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017321 ↗
• MalfunctionDec 16, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. DURING PERFUSION THERE WERE NOTICEABLE HIGH CO2 VALUES. THE HIGH VALUES COULD ONLY BE REGULATED WITH DIFFICULTY: WITH A GAS FLOW OF 8-10L/MIN. ALSO, DURING THIS SURGICAL PROCEDURE, CO2 IS ALSO INTRODUCED INTO THE OPEN THORAX (THE USUAL PROCEDURE WHEN THE HEART CAVITIES ARE OPEN TO AVOID AIR EMBOLISM LATER). OXY WAS NOT PART OF THE TERUMO TUBING PACK SET. NO SIGNIFICANT DELAY OF SURGERY. THE PATIENT'S TREATMENT WAS PERFORMED AS PLANED AND FINALIZED. THE OXY WAS NOT REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017291 ↗
• MalfunctionDec 16, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. DURING PERFUSION THERE WERE NOTICEABLE HIGH CO2 VALUES. THE HIGH VALUES COULD ONLY BE REGULATED WITH DIFFICULTY: WITH A GAS FLOW OF 8-10L/MIN. ALSO, DURING THESE SURGICAL PROCEDURES, CO2 IS ALSO INTRODUCED INTO THE OPEN THORAX (THE USUAL PROCEDURE WHEN THE HEART CAVITIES ARE OPEN TO AVOID AIR EMBOLISM LATER ON). OXY WAS NOT PART OF THE TERUMO TUBING PACK SET. NO SIGNIFICANT DELAY OF SURGERY. THE PATIENT'S TREATMENT WAS PERFORMED AS PLANED AND FINALIZED. THE OXY WAS NOT REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017254 ↗
• MalfunctionNov 1, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE OXYGENATOR HAS OXYGENATION ISSUES. THE ISSUE OCCURRED DURING CARDIOPULMONARY. THERE WAS NO DELAY, THE PRODUCT WAS NOT CHANGED OUT, NO BLOOD LOSS AND NO ADVERSE EVENT REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729330 ↗
• MalfunctionMay 10, 2018Crack; Crack

  THE USER FACILITY REPORTED DURING SET UP, THEY NOTICED A CRACKED OR SLICE IN THE PURGE LINE THAT COMES OFF AT THE TOP OF THE FIBER BUNDLE. THE OXYGENATOR WAS CHANGED OUT AND THE EVENT DID NOT DELAY BEGINNING OR CONTINUING THE SURGERY, THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503172 ↗
• MalfunctionJan 12, 2018Particulates; Particulates

  THE USER FACILITY REPORTED THAT DURING PRIME, POTTING SUBSTANCE / MATERIAL LEACHED INTO FIBER BUNDLE CAUSING MICRO AIR. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THERE WAS NO BLOOD LOSS. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185394 ↗
• MalfunctionApr 6, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Device Damaged Prior to Use; Out-Of-Box Failure

  THE USER FACILITY REPORTED THE TEMPERATURE PORT WAS FOUND BROKEN WHEN REMOVED FROM BOX. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6465211 ↗
• MalfunctionMar 23, 2017Melted; Melted

  THE USER FACILITY REPORTED THE INLET CONNECTOR MELTED ON THE CAPIOX DEVICE DURING SETUP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE PRODUCT WAS CHANGED OUT; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6427895 ↗
• MalfunctionMar 10, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE LEAKED DURING PRIME. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION; THE PRODUCT WAS CHANGED OUT; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6394690 ↗
• MalfunctionMar 8, 2017Break; Break

  THE USER FACILITY REPORTED DAMAGE TO THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION REPORTED THE FOLLOWING INFORMATION: A TUBE BROKE AT THE DE-AIRING PORT ON THE OXYGENATOR; THIS WAS NOTED WHILE PRIMING THE SYSTEM; THE OXYGENATOR WAS CHANGED OUT; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6386934 ↗
• MalfunctionFeb 8, 2017Failure to Prime; Failure to Prime

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE FAILED TO PRIME DURING SETUP. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION; THE LOCKED VOLUME OUT OF THE BOTTOM VENT WOULD NOT PRIME; IT WOULD PRIME DURING NORMOSOL; THE PRODUCT WAS CHANGED OUT; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6310339 ↗
• MalfunctionFeb 8, 2017Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED HIGH RESISTANCE ON THE CAPIOX DEVICE POST CARDIOPULMONARY BYPASS. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: NO KNOWN IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6310319 ↗
• MalfunctionOct 7, 2016Break; Break

  THE USER FACILITY REPORTED THE TEMPERATURE PROBE WAS FOUND BROKEN DURING SETUP. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PRODUCT WAS CHANGED OUT; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6011689 ↗
• MalfunctionOct 5, 2016Kinked; Kinked

  THE USER FACILITY REPORTED A KINK ON THE PURGE LINE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PURGE LINE HAD BEEN SQUEEZED TOGETHER; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6001370 ↗
• MalfunctionAug 16, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAK IN THE FX25 CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A PINHOLE LEAK OCCURRED AT THE MANIFOLD DURING PRIME. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5880152 ↗
• MalfunctionJun 23, 2016Fracture; Fracture

  THE USER FACILITY REPORTED A PURGE LINE TEAR ON THE CAPIOX FX25 DEVICE DURING PRIME. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: BROKEN PURGE PORT AT OXYGENATOR OUTLET; THE PRODUCT WAS CHANGED OUT; SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5743934 ↗