Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX15RW40CRecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00699753450790), received between May 22, 2018 and Aug 7, 2026 — classified as 3 deaths, 9 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• DeathAug 7, 2026Use of Device Problem

  The user facility reported to Terumo Cardiovascular that during cardiopulmonary bypass there was an oxygenator failure while rewarming after circulatory arrest at 28 Degrees Celsius. As per the subsidiary, it resulted to prolonged hypoxia approximately 20 minutes. There was cerebral desaturation documented by Near-Infrared Spectroscopy (NIRS). There was a significant hemodynamic instability and worsening of the patient's condition intraoperatively and postoperatively. Actions were taken through emergency replacement of the oxygenator, massive blood transfusion, device was not retained for further investigation. The subsidiary also stated that blood loss was difficult to quantify. The oxygenator content was approximately 300 mL. The oxygenator change caused significant hemodilution, requiring massive transfusion (more so than substantial blood loss).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180446 ↗
• MalfunctionDec 19, 2025Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, A FAULTY MANIFOLD ON CARDIOPULMONARY BYPASS CIRCUIT. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH LESS THAN 20 CC OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850009 ↗
• MalfunctionNov 21, 2025Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS PRODUCING FOAM. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. *PRODUCT WAS NOT CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619819 ↗
• MalfunctionMar 28, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT CARDIOPULMONARY BYPASS, THERE WAS A PLASMA LEAKAGE. NO HEALTH CONSEQUENCES OR IMPACT, PRODUCT WAS NOT CHANGED OUT, PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720482 ↗
• MalfunctionOct 11, 2024Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS THERE WAS A HIGH PRESSURE EXCURSION. AS PER THE SUBSIDIARY UPON OPENING THE PERICARDIUM, THE PATIENT WENT INTO IRRETRACTABLE VENTRICULAR TACHYCARDIA (VTACH), WITH NO PULSE. AFTER CANNULA WERE PLACED, BYPASS WAS INITIATED. PERFUSIONIST UNABLE TO REACH FULL FLOWS WITH MAXIMUM REVOLUTIONS PER MINUTE (RPM) (LESS THAN 3.0 LITERS PER MINUTE (LPM), AT 3500 RPM, CENTRIFUGAL PUMP HEAD). NO KINKS NOTED IN ANY BYPASS CIRCUIT LINES. ARTERIAL LINE OCCULDER FULLY WITHDRAWN. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED NO AORTIC DISSECTION. CANNULA PLACEMENT ADJUSTED FOR FLOW DIRECTION. PROBLEM STILL REMAINED. FEMORAL ARTERIAL LINE PLACED TO VERIFY MEAN ARTERIAL PRESSURE (MAP) OF 35. AS TIME WENT ON ABOUT 20 MINUTES, FLOWS IMPROVED UNTIL PERFUSIONIST ABLE TO FLOW 5.0 LPM AT ~2800 RPM. NO CHANGES MADE TO BYPASS CIRCUIT. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT , PRODUCT WAS NOT CHANGED OUT , PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431053 ↗
• MalfunctionMar 6, 2024Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS THERE WAS A SEVERE PRESSURE EXCURSION ON THE OXYGENATOR. THERE WAS A 15 MINUTE - MINUTE DELAY TO OPEN, PRIME AND ACTIVATE ANOTHER OXYGENATOR. NO CONSEQUENCE OR IMPACT TO PATIENT *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18850146 ↗
• MalfunctionJan 31, 2024Connection Problem; Connection Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SET UP, THE VENOUS PROBE COULD NOT GET INTO THE CONNECTOR. THEY COMPLETED THE CASE WITHOUT A VENOUS BLOOD TEMPERATURE; AS THEY DID NOT CHANGED IT OUT. *NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT *PRODUCT WAS NOT CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614399 ↗
• MalfunctionJan 26, 2024Particulates; Particulates

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, BLACK SPOTS DEBRIS WERE FOUND ALL OVER THE BOTTOM PART OF CARDIOTOMY RESERVOIR. *NO PATIENT INVOLVEMENT *PRODUCT WAS CHANGED OUT *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588045 ↗
• MalfunctionJan 5, 2024Scratched Material; Scratched Material

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR CARDIOPULMONARY BYPASS, DURING SETUP, A LINE/SCRATCH ON THE OXYGENATOR WAS NOTED. *NO KNOWN CONSEQUENCE AND IMPACT TO PATIENT. *THE PRODUCT WAS NOT CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18458118 ↗
• MalfunctionJan 2, 2024Dent in Material; Dent in Material

  DENTED VENOUS INLET PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428910 ↗
• MalfunctionNov 17, 2023Blocked Connection; Blocked Connection

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE VENOUS SAMPLING MANIFOLD RETURN LINE WAS OCCLUDED WITH A DEBRIS AT THE CONNECTION HOUSING TO THE RESERVOIR. AS PER THE SUBSIDIARY, TO MITIGATE THE ISSUE, THE USER FACILITY HAS REROUTED THE SAMPLING LINE OUTLET TO ONE OF THE LUER CONNECTORS GOING TO RESERVOIR. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161640 ↗
• MalfunctionOct 12, 2023Pressure Problem; Pressure Problem

  PRE OXYGENATOR MEMBRANE PRESSURE SLOWLY RISING AND THEN SPIKED TO ABOVE ALLOWABLE LEVELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926776 ↗
• MalfunctionSep 6, 2023Defective Component; Defective Component

  RUBBER GASKET ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694598 ↗
• MalfunctionSep 1, 2023Increase in Pressure; Increase in Pressure

  HIGH PRE-MEMBRANE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673769 ↗
• MalfunctionSep 1, 2023Crack; Crack

  CRACKED RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673761 ↗
• MalfunctionSep 1, 2023Crack; Crack

  CRACKED RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673031 ↗
• MalfunctionJul 18, 2023Contamination; Contamination

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CUSTOMER NOTICED A SMALL FOREIGN MATTER (BLACK SPOT) IN THE OXYGENATOR RESERVOIR. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341108 ↗
• MalfunctionJun 26, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  OXYGENATOR RESERVOIR HAVE CLOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199333 ↗
• MalfunctionMay 26, 2023Leak/Splash; Leak/Splash

  NEW INFORMATION RECEIVED INDICATED THAT THE EVENT OCCURRED DURING PRE-CARDIOPULMONARY BYPASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011057 ↗
• MalfunctionMay 24, 2023Low Readings; Low Readings

  THE PO2 IN CDI SHOWED GRADUAL DECREASED (FROM 32- 11 KPA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995655 ↗
• MalfunctionMar 21, 2023Air/Gas in Device; Air/Gas in Device

  THE ARTERIAL LINE HAS SMALL BUBBLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582596 ↗
• MalfunctionFeb 23, 2023Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OUT OF BOX, THE MANIFOLD CAME OUT DAMAGE. *NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427652 ↗
• MalfunctionFeb 8, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY HAVE NOTICED A BLACK MARK PARTICLE IN THE PLASTIC OF THE RESERVOIR. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323291 ↗
• InjuryFeb 1, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST STATES THAT, A PARTIAL PUMP RECORD AND ONE BLOOD GAS RESULT WAS PROVIDED BY THE CUSTOMER. FROM THIS RECORD, IT CAN BE SEEN THAT AFTER INITIATING BYPASS AT 17:38, AND WITH A SUBOPTIMUM PUMP BLOOD FLOW OF ONLY 3.5 L/MIN (AT TARGET CARDIAC INDEX OF 2.5M2 THE BLOOD FLOW SHOULD HAVE BEEN 4.75L/MIN), A BLOOD GAS RESULT WAS TAKEN AT 17:41. THIS REVEALED THE FOLLOWING: PH 7.27, PCO2 50MMHG, PO2 112MMHG. WITH GAS SWEEP OF 6 LITERS AND FIO2 SETTING OF 100%. IT IS INTERESTING TO NOTE FROM THE ONE BLOOD GAS RESULT, THAT THE ARTERIAL BLOOD SATURATION WAS 98 %, WHICH IS WITHIN AN ACCEPTABLE RANGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16276917 ↗
• MalfunctionJan 23, 2023Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE PRE-OXYGENATOR PRESSURE CONTINUED TO RISE TO THE POINT OF BEING AT A DANGEROUS LEVEL. AS PER THE SUBSIDIARY, THE USER FACILITY INFORMED THEM THAT THEY INITIALLY WENT ON CARDIOPULMONARY BYPASS WITH AS EXPECTED PRESSURES AND GAS EXCHANGE OF THE OXYGENATOR. THROUGHOUT THE CASE THE PRE OXYGENATOR (PRE MEMBRANE) PRESSURE CONTINUED TO RISE TO THE POINT OF BEING AT A DANGEROUS LEVEL. IT GOT TO THE POINT THAT THEY HAD TO TURN THE LINK ALARM OFF, AS TO NOT CAUSE THE ARTERIAL PUMP TO TURN OFF AND THEREFORE NO LONGER BE SUPPORTING THE PATIENT. THE POST OXYGENATOR PRESSURE STAYED CONSISTENT AND DID NOT INCREASE IN UNISON WITH THE PRE MEMBRANE PRESSURE. NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223573 ↗