CAPIOX®FX CX*FX25RWRecalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 04987350701046), received between Mar 18, 2016 and Jul 27, 2026 — classified as 2 deaths, 14 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 102 reports, 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionJan 30, 2026Material Deformation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING PRIMING THE OXYGENATOR BEFORE SURGERY, THE PERFUSIONIST FOUND THE PORT WAS PINCHED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, THERE WAS NO PATIENT INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223084 ↗
• MalfunctionJan 26, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE VENTING TUBE BROKE AT ITS JUNCTION WITH THE RESERVOIR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178020 ↗
• MalfunctionJan 8, 2026Tear, Rip or Hole in Device Packaging

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THERE IS A HOLE ON THE OUTER STERILE PLASTIC BAG. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003384 ↗
• MalfunctionDec 22, 2025Leak/Splash; Leak/Splash

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING THE AORTIC DISSECTION SURGERY, FOAMY BLOODY FLUID OVERFLOW FROM GAS OUTLET. NO OTHER DEVICES OR MEDICATIONS WERE USED IN CONJUNCTION DURING THE PROCEDURE. THE PLASMA LEAKAGE WAS LOCATED AT THE OXYGENATOR SITE AND DID NOT CAUSE HARM TO THE PATIENT. THE MEMBRANE OXYGENATOR WAS REPLACED DURING THE SURGERY, AND THE PATIENT IS CURRENTLY RECOVERING WELL. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873409 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. FOAMY BLOODY FLUID OVERFLOWED FROM THE GAS OUTLET AFTER CPB WAS RAN FOR MORE THAN SIX (6) HOURS. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816687 ↗
• MalfunctionSep 4, 2025Mechanical Problem; Mechanical Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. FOAM AND BUBBLES OCCURRED IN THE RESERVOIR. THE EVENT OCCURRED WHEN THE VACUUM ASSISTED VENOUS DRAINED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965074 ↗
• DeathJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT A SMALL BLOOD LEAK ARE DETECTED AT THE ARTERIAL CONNECTION PORT OUTLET DURING THE SETUP OF THE EXTRACORPOREAL CIRCUIT FOR THE PATIENT'S SURGERY. THE ISSUE WAS IDENTIFIED WHEN THE CIRCUIT WAS PRIMED. SINCE THE PATIENT WAS ALREADY CONNECTED TO THE CARDIOPULMONARY BYPASS (CPB) AND THERE WAS INSUFFICIENT TIME TO REPLACE THE CIRCUIT, THE LEAK WAS RESOLVED BY APPLYING A TEGADERM TO PREVENT A HIGH-RISK SITUATION. THE PATIENT EXPERIENCED HYPOTENSION AND AIRWAY BLEEDING, WHICH WAS THE CAUSE OF DEATH.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22343103 ↗
• MalfunctionMay 30, 2025Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED THAT THERE WAS AIR BUBBLING AT PRIMING WITH TWO DEVICES. THE THIRD DEVICE WORKED PROPERLY AND THEY WERE ABLE TO PROCEED WITH SURGERY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114364 ↗
• MalfunctionMay 30, 2025Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED THAT THERE WAS AIR BUBBLING AT PRIMING WITH TWO DEVICES. THE THIRD DEVICE WORKED PROPERLY AND THEY WERE ABLE TO PROCEED WITH SURGERY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114358 ↗
• MalfunctionMay 28, 2025Packaging Problem; Packaging Problem

  THE USER FACILITY REPORTED THAT THEY HAD FAULTY PACKAGING UPON OPENING. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096657 ↗
• InjuryApr 21, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THEY HAD A MINIMALLY INVASIVE CARDIAC SURGERY (MICS) PROCEDURE, AT THE BEGINNING OF THE CARDIOPULMONARY BYPASS (CPB), BLOOD FLOW 1.3L/MIN, PRE-OXYGENATOR PRESSURE 230MMHG, FEMORAL ARTERY CANNULAE 18 FR., NO OTHER PROBLEMS WERE FOUND, REPLACED THE OXYGENATOR, EVERYTHING BECAME NORMAL. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED. SINCE THE OXYGENATOR WAS EXCHANGED, IT WAS DETERMINED TO BE A SERIOUS INJURY, HOWEVER, THERE WAS NO HEALTH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878788 ↗
• MalfunctionFeb 5, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER REPORTED THAT ONCE OPENING THE PACKAGE, LOOSE PART WAS FOUND. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315286 ↗
• MalfunctionJan 9, 2025Break; Break

  THE USER FACILITY REPORTED THAT DURING PRIMING, THE PURGE LINE WAS FOUND TO BE BROKEN. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, THERE WAS NO PATIENT HARMED OR INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112304 ↗
• InjuryDec 6, 2024Failure to Deliver; Failure to Deliver

  THE USER FACILITY REPORTED THAT AFTER 2.5 HOURS OF BYPASS, THE OXYGENATOR WAS CHANGED OUT DUE TO OXYGENATION FAILURE. THE PATIENT'S BODY SURFACE AREA (BSA) WAS 1.99. BYPASS STARTED AT 10:22 AND CONTINUED UNTIL 12:47, WITH FIO2 MAINTAINED BETWEEN 57% AND 70%. THE CDI 550 WAS CALIBRATED PERIODICALLY USING 1X VBG AND 4X ABG. NASO TEMPERATURE RANGED FROM 30-35°C, AND PO2 FROM ABG VARIED BETWEEN 247-320 MMHG. AT 12:58, FIO2 AND SWEEP GAS WERE INCREASED TO 80% AND 8, RESPECTIVELY, WITH A VBG OF 59%. DESPITE THESE HIGH SETTINGS, PO2 ON CDI WAS BETWEEN 100-150 MMHG, SVO2 BETWEEN 50-60%, AND PCO2 60-70 MMHG, WITH A NASO TEMPERATURE OF 28°C FROM 12:58 TO 13:24. A DECISION WAS MADE TO CHANGE OUT THE OXYGENATOR AT 13:24. CARDIOPULMONARY BYPASS (CPB) WAS STOPPED FOR 45 SECONDS, AND THE PATIENT WAS REWARMED AT 13:25. AFTER THE OXYGENATOR CHANGEOUT, FIO2 WAS SET AT 60% WITH A SWEEP OF 3.8. PO2 AND PCO2 WERE 229 MMHG AND 37.5 MMHG ON ABG DONE AT 13:30. THERE WERE NO MORE GAS TRANSFER ISSUES AFTER THE CHANGEOUT, WITH FIO2 SET AT 60-74% AND SWEEP AT 2.1-2.8. THE PATIENT WAS SUCCESSFULLY WEANED OFF THE BYPASS AT 14:30. THE SAMPLE WAS DISCARDED DUE TO BLOOD CONTAMINATION. THE INVOLVED PRODUCT WAS REPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861164 ↗
• MalfunctionNov 4, 2024Break; Break

  THE USER FACILITY REPORTED THAT ONCE OPENING THE PACKAGE, THE CONNECTOR OF PURGE LINE TO RESERVOIR WAS FOUND TO BE BROKEN. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597448 ↗
• MalfunctionSep 9, 2024Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE SAMPLING PART WAS DAMAGED AFTER THEY OPENED THE PLASTIC PACKAGE. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168452 ↗
• MalfunctionJul 25, 2024Crack; Noise, Audible; Crack; Noise, Audible

  THE USER FACILITY REPORTED THAT DURING PRIMING, THE PERFUSIONIST HEARD AN ABNORMAL NOISE AND DETECTED A CRACK. ACCORDING TO THE FEEDBACK OF THE HEALTH CARE PROFESSIONAL (HCP), SHE FOUND THAT SOME BUBBLES WERE DIFFICULT TO DISCHARGE WHEN SHE PRE-FILLED TO EXHAUST GAS (5L FLOW RATE). SHE THEN ATTEMPTED TO SLAP THE DEVICE TO ACCELERATE THE EXHAUSTION; HOWEVER, IT DID NOT TAKE EFFECT. THEREFORE, SHE TOOK THE DEVICE OFF THE BRACKET AND SLAPPED THE DEVICE DIAGONALLY. THE SHE HEARD SOME SOUND OF CRACKING AND FOUND THE DEVICE DAMAGED. THE OXYGENATOR AND RESERVOIR WERE NOT SEPARATED TO USE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828215 ↗