CAPIOXRXRecalls & reported problems across all models

We found 9 models of CAPIOXRX by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Feb 18, 2016 and Aug 22, 2025 — classified as 2 deaths, 25 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (41 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 CAPIOXRX problems

CAPIOXRX models

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

• CAPIOX®RX CX*RX25RW

  Oxygenator, Cardiopulmonary Bypass
  1 death102 reports
• CAPIOX®RX CX*RX25RE

  Oxygenator, Cardiopulmonary Bypass
  17 reports
• CAPIOX®RX CX*RX05RW

  Oxygenator, Cardiopulmonary Bypass
  1 death15 reports
• CAPIOX®RX CX*RX15RW30

  Oxygenator, Cardiopulmonary Bypass
  14 reports
• CAPIOX®RX CX*RX15RW40

  Oxygenator, Cardiopulmonary Bypass
  5 reports
• CAPIOX®RX CX*RX15RE40

  Oxygenator, Cardiopulmonary Bypass
  4 reports
• CAPIOX®RX CX*RX05RE

  Oxygenator, Cardiopulmonary Bypass
  2 reports
• CAPIOX®RX CX*RX15RE30

  Oxygenator, Cardiopulmonary Bypass
  2 reports
• CAPIOX®RX CX*RX25W

  Oxygenator, Cardiopulmonary Bypass
  1 report

Recent CAPIOXRX adverse event reports

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

• MalfunctionAug 22, 2025Break; Break

  THE USER FACILITY REPORTED THAT THE SAMPLING TUBE AT THE VENOUS END WAS BROKEN. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878077 ↗
• InjuryMar 5, 2025Gas Output Problem; Failure to Deliver; Gas Output Problem; Failure to Deliver

  THE USER FACILITY REPORTED LOW OXYGENATION WITH THE INVOLVED CAPIOX. THE INCIDENT OCCURRED DURING PATIENT ON BYPASS (CARDIOVASCULAR). THE DARK BLOOD IN CIRCULATION NOTICEABLE AFTER CROSS CLAMP. THE OXYGENATOR EXCHANGE WAS CONDUCTED AFTER AORTIC CROSS CLAMP OFF/UNCLAMPED. THE NEW OXYGENATOR WORKING WELL UNTIL END OF THE CASE. THE PATIENT WAS REPORTED STABLE AND WITH NO HARM. THE INVOLVED PRODUCT WAS REPLACED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525793 ↗
• InjuryJan 28, 2025Failure to Deliver; Failure to Deliver

  THE USER FACILITY REPORTED THAT LOW OXYGENATION OCCURRED. THE INCIDENT OCCURRED WHEN THE PATIENT WAS ON BYPASS (CARDIOVASCULAR). THE ARTERIAL BLOOD WAS NOTICEABLY DARK AFTER BYPASS; ROUGHLY TEN MINUTES DESPITE INCREASING FIO2, BLOOD AND GAS FLOW. ARTERIAL BLOOD GAS (ABG) WAS PERFORMED AND FOUND THAT THE PO2, PCO2 AND LACTIC ACID WAS HIGH. ABG WAS PERFORMED AFTER FIO2, GAS AND CPB FLOWS WAS MAXIMIZED WITH MARGINAL IMPROVEMENT. THE OXYGENATOR WAS CHANGED AND PERFORMED. ALL PARAMETERS IMPROVED WITH STANDARD FIO2 AND CPB FLOW. THE EVENT IS DEEMED AS SERIOUS SINCE THE DEVICE WAS REPLACED; HOWEVER, THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252318 ↗
• InjuryDec 9, 2024Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED THAT AS SOON AS CPB START, THE AIR BUBBLES WERE FOUND AND COULD NOT BE REMOVED. A NEW DEVICE WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HEALTH HAZARD TO THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878123 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE OCCURRED. DURING PRIMING, THE PERFUSIONIST FOUND LIQUID WAS COMING OUT OF THE GAS OUTLET. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVED/HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662081 ↗
• MalfunctionOct 5, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE COCK SYSTEM WAS BROKEN. THE EVENT OCCURRED PRIOR TO TREATMENT, THEREFORE THERE WAS NO PATIENT INVOLVEMENT. THE FINAL PATIENT IMPACT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20379385 ↗
• InjuryJul 31, 2024Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT DURING SURGERY, FIRST STAGE OXYGENATION DID NOT WORK IN THIS OXYGENATOR. AT THE SAME TIME, THE USER CHANGES THE OXYGENATOR PART ONLY AND THE RESERVOIR REMAINS THE SAME. AFTER THAT, THE OXYGENATION WORKS, AND THE SURGERY CONTINUES. GAS LINE/SUPPLY ARE OKAY. FIO2 IS ALSO SUFFICIENT. THE EVENT OCCURRED INTRA-OPERATIVELY. THE PATIENT'S FINAL IMPACT WAS NOT HARMED. NO PATIENT'S HARM WAS CAUSED BY THIS INCIDENT, BUT THE PRODUCT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19879304 ↗
• MalfunctionJul 11, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT FOUR (4) HOURS AFTER CPB WAS STARTED, THE PERFUSIONIST DISCOVERED BLOODY FLUIDS HAD LEAKED OUT OF THE GAS OUTLET OF THE INVOLVED OXYGENATOR, LOTS OF BUBBLES APPEARED. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721722 ↗
• MalfunctionMay 15, 2024Break; Break

  THE USER FACILITY REPORTED THAT IT WAS FOUND THAT THE TUBE WAS BROKEN AT THE CONNECTION DURING THE EXAMINATION BEFORE THE OPERATION. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319769 ↗
• MalfunctionApr 25, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE SAMPLING TUBE WAS BROKEN. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182253 ↗
• MalfunctionJan 31, 2024Break; Leak/Splash; Break; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE WITH THE CAPIOX DEVICE INVOLVED. THE SAMPLING LINE WAS BROKEN AT THE CONNECTION WITH BLOOD INLET. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614081 ↗
• MalfunctionJan 31, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX LEAKAGE WAS NOTICED BY THE PERFUSIONIST WHEN THEY STARTED THE PRIMING OF THE OXYGENATOR BEFORE THE START OF SURGERY. THE CAPIOX WAS REPLACED WITH A FRESH AND THE SURGERY WAS NOT INTERRUPTED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614080 ↗
• MalfunctionDec 20, 2023Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED POOR OXYGENATION DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE. PO2 50 MMHG, BLOOD FLOW RATE 5L/MIN, GAS FLOW RATE 2.5L/MIN, FIO2 75%. BECAME NORMAL AFTER THE OXYGENATOR WAS REPLACED WITH A NEW RX25. NO PATIENT HARM WAS REPORTED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363458 ↗
• MalfunctionNov 22, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED POOR OXYGENATION. IT WAS REPLACED WITH A NEW RX05; HOWEVER, THE OXYGENATION DID NOT IMPROVE. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO HEALTH HAZARD ATTRIBUTABLE TO THE EVENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193464 ↗
• MalfunctionNov 22, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED POOR OXYGENATION. IT WAS REPLACED WITH A NEW RX05; HOWEVER, THE OXYGENATION DID NOT IMPROVE. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO HEALTH HAZARD ATTRIBUTABLE TO THE EVENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193346 ↗

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