CAPIOXFXRecalls & reported problems across all models

We found 12 models of CAPIOXFX by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 328 adverse event reports in the FDA's MAUDE database, received between Jan 27, 2016 and Jul 27, 2026 — classified as 2 deaths, 65 injuries, 261 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (78 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CAPIOXFX problems

CAPIOXFX models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CAPIOX®FX CX*FX25RW

  Oxygenator, Cardiopulmonary Bypass
  2 deaths102 reports
• CAPIOX®FX CX*FX05RW

  Oxygenator, Cardiopulmonary Bypass
  74 reports
• CAPIOX®FX CX*FX25E

  Oxygenator, Cardiopulmonary Bypass
  26 reports
• CAPIOX®FX CX*FX25RE

  Oxygenator, Cardiopulmonary Bypass
  24 reports
• CAPIOX®FX CX*FX05RE

  Oxygenator, Cardiopulmonary Bypass
  23 reports
• CAPIOX®FX CX*FX15E

  Oxygenator, Cardiopulmonary Bypass
  19 reports
• CAPIOX®FX CX*FX15RW40

  Oxygenator, Cardiopulmonary Bypass
  17 reports
• CAPIOX®FX CX*FX15RW30

  Oxygenator, Cardiopulmonary Bypass
  17 reports
• CAPIOX®FX CX*FX25W

  Oxygenator, Cardiopulmonary Bypass
  14 reports
• CAPIOX®FX CX*FX15W

  Oxygenator, Cardiopulmonary Bypass
  8 reports
• CAPIOX®FX CX*FX15RE40

  Oxygenator, Cardiopulmonary Bypass
  2 reports
• CAPIOX®FX CX*FX15RE30

  Oxygenator, Cardiopulmonary Bypass
  2 reports

Recent CAPIOXFX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011508 ↗
• MalfunctionMay 29, 2026Break

  TERUMO CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PURGE LINE WAS FOUND BROKEN BEFORE USE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331006 ↗
• MalfunctionMay 15, 2026Material Deformation

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE STERILE PACKAGING BAG WAS DAMAGED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186239 ↗
• MalfunctionMay 12, 2026Failure to Deliver

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE OXYGENATOR DID NOT FUNCTION PROPERLY DURING A LUNG TRANSPLANT WHEN THEY WENT ON BYPASS. THE LUNG WAS ALREADY OUT OF THE BODY; THEREFORE, THEY INCREASED THEIR SWEEP TO 10 TO LIMP BY UNTIL THEY TRANSITIONED TO CARDIO HELP. THEREFORE, THEY DID NOT CHANGE THE OXY OUT. THERE WAS NO DELAY OR INJURY OR PATIENT DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149808 ↗
• MalfunctionMay 6, 2026Leak/Splash; Air/Gas in Device

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THERE WAS AIR IN THE FILTER. THE EVENT OCCURRED DURING BYPASS, THE PATIENT WAS INVOLVED. THE END OF THE PROCEDURE (4 HRS 12 MIN), THIRD PARTY TUBING PACK. THE PROCEDURE WAS NOT DELAYED, AND THE DEVICE WAS NOT REPLACED. THERE WAS NO IMPACT ON PATIENT, PATIENT TREATED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25102146 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component; Material Deformation

  TERUMO RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT WHEN THE PRODUCT WAS UNPACKED IT WAS FOUND THAT THE YELLOW PART ON THE TOP (SAMPLING SYSTEM) WAS BROKEN AND FELL OFF. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948694 ↗
• MalfunctionMar 30, 2026Clumping in Device or Device Ingredient

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE DEFECT WAS IDENTIFIED BEFORE APPLICATION TO THE PATIENT. CLOTTING WAS OBSERVED IN THE RESERVOIR FILTER DESPITE ADEQUATE HEPARINIZATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE PROCEDURE WAS DELAYED DUE TO A PRODUCT ISSUE IDENTIFIED PRIOR TO PATIENT USE. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714368 ↗
• 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 ↗
• MalfunctionMar 11, 2026Failure to Deliver

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: ON (B)(6) 2026: AT 15:15, THE PATIENT UNDERWENT A TOTAL AORTIC ARCH REPLACEMENT WITH ARTIFICIAL BLOOD VESSEL, PARTIAL RESECTION OF THE ASCENDING AORTA WITH ARTIFICIAL BLOOD VESSEL REPLACEMENT, FROZEN ELEPHANT TRUNK PROCEDURE. SINGLE CORONARY ARTERY BYPASS GRAFTING (AORTOCORONARY BYPASS) AND AORTIC VALVULOPLASTY AS PRESCRIBED. AT 16:48, DURING THE PROCEDURE CARDIOPULMONARY BYPASS WAS ESTABLISHED BASED ON SURGICAL REQUIREMENTS, AT WHICH TIME AN "INTEGRATED MEMBRANE OXYGENATOR" WAS UTILIZED. PRIOR TO USE, THE ASSISTANT INSPECTED THE PRODUCT'S OUTER PACKAGING AND FOUND NO ABNORMALITIES ON THE EXTERNAL SURFACE. THE SURGERY PROCEEDED SMOOTHLY. AT 22:21, THE BYPASS CIRCUIT WAS FUNCTIONING NORMALLY, WITH AN OXYGEN PARTIAL PRESSURE READING OF 445 MMHG (FIO2 80%) AND THE SURGERY CONTINUED. AT 23:29: THE OXYGEN PARTIAL PRESSURE SUDDENLY DROPPED TO 89 MMHG (FIO2 80%) INDICATING SEVERE OXYGENATOR FAILURE. THE ATTENDING SURGEON IMMEDIATELY PAUSED THE SURGERY AND CAREFULLY INSPECTED THE CIRCUIT BUT FOUND NO ABNORMALITIES. THE FIO2 WAS PROMPTLY INCREASED TO 100% WHICH RESULTED IN SLIGHT IMPROVEMENT, THOUGH IT DID NOT MEET CLINICAL REQUIREMENTS. O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570087 ↗
• InjuryMar 5, 2026Improper Flow or Infusion

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR EXPERIENCED A SUDDEN DROP IN PUMP FLOWS; POTENTIAL HPE SITUATION. 45 MINUTES POST XCLAMP, FLOWS SUDDENLY DROPPED TO ABOUT .8 C.I. THERE WERE NO KINKS IN THE A LINE OR THE CANNULA. OXYGENATION, CO2, AND ACTS REMAINED NORMAL. REWARMING WAS ATTEMPTED WITH REPOSITIONING OF THE XCLAMP WITH NO CHANGE. RPMS WERE MAXED AND WITH VERY LOW FLOWS. FEMORAL CANNULATION WAS ATTEMPTED WITH NO CHANGE. THE FLOW PROBE WAS REPOSITIONED WITH NO CHANGE. A NEW PUMP WAS BROUGHT IN AND NORMAL FLOWS WERE RESUMED; THE PROCEDURE WAS COMPLETELY SUCCESSFULLY. THE PATIENT EXPERIENCED LOW FLOWS FOR 18 MIN WITH SYSTOLIC PRESSURES IN THE 30'S. THE PATIENT HAD POLYCYTHEMIA VERA WHICH CARRIES AN INCREASED RISK OF CLOTTING ON BYPASS EVEN WITH PROPER ACT LEVELS. THE CUSTOMER WAS SUSPICIOUS OF HIGH-PRESSURE EXCURSION. THE EVENT RESULTED IN DELAYS OF THE SURGICAL PROCEDURE. 800 ML OF BLOOD LOSS WAS A RESULT OF THE REPORTED ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24520769 ↗
• MalfunctionMar 2, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: BLOOD SAMPLING THREE WAY BROKEN AND BLOCKED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480175 ↗
• MalfunctionMar 2, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE SAMPLING TUBE BROKE AT THE CONNECTION TO THE BLOOD INLET PORT OF THE RESERVOIR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480161 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING PRIMING THE PUMP ONE OF THE 3-WAY CONNECTORS ON THE OXYGENATOR SAMPLING PORT WAS FOUND TO BE COMPLETELY DETACHED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388382 ↗
• 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 ↗

Other Terumo Corporation products

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• NAVICROSS11 models · 49 reports
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