CAPIOX®RX CX*RX25RWRecalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 04987350769572), received between Apr 27, 2016 and Aug 22, 2025 — classified as 1 death, 12 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Break” (30 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.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 31, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE INVOLVED HAD LEAKAGE. THE USER STARTED PRIMING AS USUAL, AND A LEAK AT THE WATER OUTLET WAS FOUND. THE USER CHANGED TO A NEW OXYGENATOR. THE PATIENT WAS REPORTED TO BE SAFE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038721 ↗
• MalfunctionJun 27, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THERE WAS NO ABNORMALITY IN APPEARANCE OF THE OXYGENATOR, THE PERFUSIONIST BUILT A CIRCUIT WITH IT AND PRIMED AS NORMAL. BEFORE THE CPB CIRCUIT CONNECTED TO PATIENT, THE PERFUSIONIST STARTED CIRCULATION IN CIRCUIT, THE PRIMING SOLUTION IN RESERVOIR DISAPPEARED, THEN RE-ADD 500ML PRIMING SOLUTION, START PUMP AGAIN, PRIMING SOLUTION DISAPPEARED AGAIN. SO THE PERFUSIONIST JUDGES THAT IT IS A OXYGENATOR QUALITY PROBLEMS. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213807 ↗
• InjuryJun 1, 2023Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE HAD POOR OXYGENATION AFTER THREE (3) HOURS CARDIOPULMONARY BYPASS (CPB). AT THAT TIME AORTIC UNCLAMPED AND HEARTBEAT WAS RECOVERED. THE OXYGENATOR WAS REPLACED WITH A NEW RX25. TOTAL CPB TIME WAS ABOUT 350 MINS. THE PATIENT FINAL IMPACT WAS NOT HARMED. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039197 ↗
• InjuryMay 30, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT POOR OXYGENATION OCCURRED AFTER 215 MINUTES CARDIOPULMONARY BYPASS (CPB). THE OXYGENATOR WAS REPLACED. CPB TOTAL TIME WAS 450 MINUTES. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019551 ↗
• MalfunctionApr 17, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE SAMPLING SYSTEM WAS BROKEN UPON UNPACKED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16758926 ↗
• MalfunctionMar 14, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE JUNCTION BETWEEN THE OXYGENATOR AND RESERVIOR WAS BROKEN. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537815 ↗
• MalfunctionNov 23, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE USER FACILITY REPORTED THAT THERE WAS LOW OXYGENATION AND POOR OXYGENATION DURING REWARMING OF THE CAIPOX DEVICE INVOLVED. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851292 ↗
• MalfunctionOct 3, 2022No Flow; No Flow

  THE USER FACILITY REPORTED THAT NO OXYGENATION WAS FOUND AFTER THE CPB RAN, PO2 50-60 MMHG. AFTER THE CIRCUIT WAS CHECKED, NO GAS FLOW FROM THE GAS OUTLET WAS FOUND, EVEN IF GAS FLOW SETTING WAS 8.0L/MIN. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PRODUCT WAS NOT REPLACED. THE PROCEDURE WAS SWITCHED TO OFF-PUMP SURGERY. THE PROVIDED VIDEO WAS CHECKED, AND IT WAS FOUND THAT A TUBE WAS INSERTED INTO THE GAS OUT OF THE OXYGENATOR; HOWEVER, THE TUBE CONNECTION ON THE IN PORT SIDE COULD NOT BE FOUND. THE GAS LINE WAS INSTALLED CORRECT. THE AIR-IN PORT WAS CONNECTED WITH A TUBE FROM THE GAS SOURCE. THE GAS FLOW FROM THE GAS SOURCE WAS NORMAL. THE GAS FLOW WAS TESTED BY CONNECTING THE GAS OUT PORT WITH A TUBE AND PUTTING IT INTO WATER. IT WAS FOUND THAT THERE WAS NO GAS FLOW FROM THE OUT PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15531534 ↗
• MalfunctionAug 8, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT WHILE PRIMING THE CAPIOX DEVICE CPB CIRCUIT, THE PERFUSIONIST OBSERVED THAT THERE WAS AIR BUBBLE FORMATION INSIDE THE OXYGENATOR CHAMBER WHICH WAS QUITE SIGNIFICANT AND FORCED HIM TO REPLACE THE OXYGENATOR WITH NEW ONE. THIS WAS OBSERVED WHEN HE WAS TRYING TO STOP THE PUMP AND THE AIR COULD BE SEEN GOING INTO THE ARTERIAL LINE. REPLACEMENT OF THE OXYGENATOR WITH NEW ONE. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188174 ↗
• MalfunctionJun 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT A PROBLEM OCCURRED WHILE USING THE OXYGENATOR AS DURING THE PRIMING AIR BUBBLES WAS NOTED COMING OUT OF THE ARTERIAL AND CARDIOPLEGIA OUTLET OF THE OXYGENATOR. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828299 ↗
• MalfunctionMay 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT AT THE TIME OF PRIMING THE OXYGENATOR WITH CRYSTALLOID FLUID, THE AIR BUBBLES WERE CONSISTENTLY SEEN OVER THE MEMBRANE OF THE RX25 OXYGENATOR EVEN AFTER PRIMING AND RECIRCULATING IT FOR THE SIGNIFICANT TIME. THE BUBBLES KEPT ARISING FROM THE BOTTOM OF THE OXY TRAVELLING TO THE TOP AND EVENTUALLY ENTERING THE ARTERIAL LINE OF THE CIRCUIT. HOWEVER, IT WAS OBSERVED THAT THE BUBBLES WERE FORMED WHEN THE PUMP WAS SUDDENLY STOPPED AND WITH GRADUAL REDUCTION OF THE PUMP SPEED, BUBBLES WERE NOT OBSERVED. THE OXYGENATOR WAS REPLACED WITH NEW RX25 OXYGENATOR. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498627 ↗
• MalfunctionApr 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT AT THE TIME OF PRIMING THE OXYGENATOR WITH CRYSTALLOID FLUID, THE AIR BUBBLES WERE CONSISTENTLY SEEN OVER THE MEMBRANE OF THE RX25 OXYGENATOR EVEN AFTER PRIMING AND RECIRCULATING IT FOR THE SIGNIFICANT TIME. THE BUBBLES KEPT ARISING FROM THE BOTTOM OF THE OXY TRAVELLING TO THE TOP AND EVENTUALLY ENTERING THE ARTERIAL LINE OF THE CIRCUIT. HOWEVER, IT WAS OBSERVED THAT THE BUBBLES WERE FORMED WHEN THE PUMP WAS STOPPED ABRUPTLY AND WITH GRADUAL REDUCTION OF THE PUMP SPEED, BUBBLES WERE NOT TO BE SEEN. THE OXYGENATOR WAS NOT REPLACED, AND THE PROCEDURE WAS CONTINUED AS NORMAL. THE EVENT HAD NO IMPACT ON THE FUNCTIONING OF THE OXYGENATOR THROUGHOUT THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT WHEN THE EVENT OCCURRED. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT'S FINAL IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14205194 ↗
• MalfunctionApr 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT AT THE TIME OF PRIMING OXYGENATOR WITH CRYSTALLOID FLUID, THE AIR BUBBLES WERE CONSISTENTLY SEEN OVER THE MEMBRANE OF THE RX25 OXYGENATOR EVEN AFTER PRIMING AND RECIRCULATING IT FOR THE SIGNIFICANT TIME. THE BUBBLES KEPT ARISING FROM THE BOTTOM OF THE OXY TRAVELLING TO THE TOP AND EVENTUALLY ENTERING THE ARTERIAL LINE OF THE CIRCUIT. HOWEVER, IT WAS OBSERVED THAT THE BUBBLES WERE FORMED WHEN THE PUMP WAS STOPPED ABRUPTLY AND WITH GRADUAL REDUCTION OF THE PUMP SPEED, BUBBLES WERE NOT TO BE SEEN. THE OXYGENATOR WAS NOT REPLACED, AND THE PROCEDURE WAS CONTINUED AS NORMAL. NO EVENT WAS REPORTED. THE EVENT HAS NO IMPACT ON THE FUNCTIONING OF THE OXYGENATOR THROUGHOUT THE PROCEDURE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14195157 ↗
• MalfunctionApr 25, 2022Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED THAT AT THE TIME OF PRIMING THE OXYGENATOR WITH CRYSTOLLOID FLUID, AIR BUBBLES WERE CONSISTENTLY SEEN OVER THE MEMBRANE OF THE RX25 OXYGENATOR. THE AIR BUBBLES WERE SEEN AFTER PRIMING AND RECIRCULATING THE DEVICE FOR A SIGNIFICANT AMOUNT OF TIME. THE BUBBLES WERE RISING FROM THE BOTTOM OF THE OXYGENATOR, TRAVELLING TO THE TOP, AND EVENTUALLY THE BUBBLES ENTERED THE ARTERIAL LINE OF THE CIRCUIT. IT WAS OBSERVED THAT THE BUBBLES WERE FORMED WHEN THE PUMP WAS STOPPED ABRUPTLY. WITH GRADUAL REDUCTION OF THE PUMP SPEED, BUBBLES WERE NOT TO BE SEEN. THE OXYGENATOR WAS NOT REPLACED, AND THE PROCEDURE WAS CONTINUED AS NORMAL. NO EVENT WAS REPORTED. THE EVENT HAD NO IMPACT ON THE FUNCTIONING OF THE OXYGENATOR THROUGHOUT THE PROCEDURE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NO HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192943 ↗
• MalfunctionApr 20, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT AT THE TIME OF PRIMING OXYGENATOR WITH CRYSTALLOID FLUID, THE AIR BUBBLES WERE CONSISTENTLY SEEN OVER THE MEMBRANE OF THE RX25 OXYGENATOR EVEN AFTER PRIMING AND RECIRCULATING IT FOR THE SIGNIFICANT TIME. THE BUBBLES KEPT ARISING FROM THE BOTTOM OF THE OXY TRAVELLING TO THE TOP AND EVENTUALLY ENTERING THE ARTERIAL LINE OF THE CIRCUIT. HOWEVER, THEY COULDN'T FIND ANY VISIBLE CRACK OR ANY LEAKAGE ON THE OXYGENATOR. THERE WAS NO PATIENT INVOLVEMENT WHEN THE EVENT OCCURED. THE EVENT OCCURRED PRE-TREATMENT. ADDITIONAL WAS RECEIVED ON 11 APRIL 2022: YES, THE ROLLER PUMP WAS USED TO THE BCP PORT. THE FLOW RATE OF CARDIOPLEGIA PUMP WAS AROUND 150-250ML/MIN. THE TYPE OF PUMP IN THE MAIN CIRCUIT WAS A ROLLER PUMP, AND THE FLOW RATE DURING PRIMING WAS 3-4 LPM. THE PUMP WAS ABRUPTLY STOPPED DURING PRIMING WITH THE CONTROL KNOB WHILE CLAMPING THE ARTERIAL LINE TO CHECK THE OCCLUSION AND JUST BEFORE THE LINE WERE DIVIDED ON THE SURGICAL AREA FOR CANNULATION. NO GAS BLOWING WAS PERFORMED. THE WAS NOT STOPPED ABRUPTLY. IT'S A PART OF PROTOCOL DONE WHILE CLAMPING THE VENOUS OR ARTERIAL LINE TO CHECK THE OCCLUSION OR IF IT HAPPENS DUE TO HIGH PRESSURE MORE THAN SET LIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14163448 ↗
• MalfunctionDec 23, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. DURING CPB, GAS EXCHANGE WAS NOT GOOD, EVEN IF INCREASING GAS SUPPLYING AND FIO2. AT THE SAME TIME, BUBBLES CONTINUE TO FLOW OUT FROM THE PORT (1/4-3/8 PORT) NEXT TO THE VENOUS INLET PORT. THE PATIENT WAS NOT HARMED. THE PATIENT OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13075108 ↗
• MalfunctionDec 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT DURING PRIMING OF THE CAPIOX DEVICE, THERE WAS AIR COMING FROM ARTERIAL OUTLET. THERE WAS NO DELAY IN THE PROCEDURE, THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT EFFECT, THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060568 ↗
• MalfunctionDec 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT DURING PRIMING OF THE CAPIOX DEVICE, THERE WAS AIR COMING FROM ARTERIAL OUTLET. THERE WAS NO DELAY IN THE PROCEDURE, THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT EFFECT, THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060382 ↗