Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX25RWRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00699753450110), received between Jun 7, 2018 and Jun 5, 2023 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (7 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Leak/Splash; Leak/Splash

  LEAKING PLASMA CREATING WHITE FOAM FROM THE GAS OUTLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061986 ↗
• MalfunctionNov 10, 2022Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE MANIFOLD MALFUNCTIONED; THE LUER CONNECTION AT THE PROXIMAL END BEFORE THE FIRST STOPCOCK CAME APART. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774669 ↗
• MalfunctionDec 21, 2021Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY, DURING SETUP, THEY NOTICED A BROKEN CONNECTOR COMING OFF THE OXYGENATOR. NO PATIENT INVOLVEMENT; PRODUCT WAS CHANGED OUT; PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052754 ↗
• MalfunctionApr 1, 2021Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, AIR BUBBLES WERE NOTED COMING OUT OF THE ARTERIAL AND CARDIOPLEGIA OUTLET OF THE OXYGENATOR. NO HEALTH CONSEQUENCES OR IMPACT. DELAY OF ABOUT 30 MINUTES. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605540 ↗
• MalfunctionMar 19, 2021Component Missing; Component Missing

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THERE WAS NO CONNECTION PORT IN THE WRAPPING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11525758 ↗
• MalfunctionMar 10, 2021Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, WHEN THE VENOUS PROBE WAS CONNECTED, IT BROKE AND FELL OFF. THE CASE WAS COMPLETED WITHOUT VENOUS TEMP IN LINE. *NO HEALTH CONSEQUENCES OR IMPACT THE PRODUCT WAS NOT CHANGED OUT *THE SURGERY WAS COMPLETED SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456884 ↗
• MalfunctionFeb 10, 2021Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, AFTER THE WATER CONNECTIONS WERE SECURE FROM THE OXYGENATOR TO THE HEATER COOLER, THE FIBERS BEGAN TO FILL UP WITH FLUID. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306995 ↗
• MalfunctionJan 12, 2021Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS A BENT PORT ON THE MANIFOLD. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11153653 ↗
• MalfunctionNov 16, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THEY NOTICED LEAKAGE FROM MANIFOLD. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10848734 ↗
• MalfunctionSep 25, 2020Packaging Problem; Packaging Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING A NON CLINICAL ACTIVITY; THE OUTER BOX TAPE OF AN OXYGENATOR UNIT WAS NOTED TO HAVE A DOUBLE LAYER OF TAPE, MAKING THE USER FEEL THAT THE ORIGINAL SEAL WAS BROKEN. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10588177 ↗
• MalfunctionApr 8, 2020Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, NOTED THE FILTER IS NOT INTACT AND WAS FALLEN FROM THE SEAM. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9935888 ↗
• MalfunctionFeb 4, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED TO TERUMO CARDIOVASCULAR THAT, DURING OTHER - NON CLINICAL ACTIVITY, THERE WERE 4 MISSING OXYGENATORS THAT DID NOT ARRIVE IN THE WAREHOUSE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9667764 ↗
• MalfunctionNov 1, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ARTERIAL THERMISTOR DID NOT RECORD THE TEMPERATURE. AS PER USER FACILITY, THE CABLE WAS FINE WHEN THEY TESTED IT ON THE VENOUS THERMISTOR PORT AND WAS ABLE TO RECORD THE TEMPERATURE. NO CONSEQUENCES OR IMPACT TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269037 ↗
• MalfunctionNov 1, 2019Obstruction of Flow; Obstruction of Flow

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ONE WAY VALVE ON THE OXY SAMPLING PORT IS BLOCKED, AND HAS A SLOW FLOW. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9268922 ↗
• MalfunctionSep 13, 2019Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL SIDE OF MANIFOLD LINE COLLAR IS ROTATING BUT LINE WILL NOT PULL OFF MANIFOLD. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PRODUCT WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 9048726 ↗
• MalfunctionSep 12, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE ARTERIAL THERMISTOR ON THE OXYGENATOR FAILED FOR IT DID NOT RECORD TEMPERATURE. AS PER THE USER FACILITY, THE CABLE WAS FINE AS THEY TESTED IT ON THE VENOUS THERMISTOR PORT AND IT RECORDED THE TEMPERATURE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9006542 ↗
• MalfunctionJul 26, 2019Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  THE DISTRIBUTOR REPORTED TO TERUMO CARDIOVASCULAR THAT UPON RECEIPT OF THE SHIPMENT THERE WERE 48 PIECES TOO FEW OF THE DEVICE AS COMPARED TO THE SHIP LIST. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8833840 ↗
• MalfunctionJul 19, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, A DEVICE WITH DIFFERENT PART NUMBER WAS RECEIVED.   NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8809311 ↗
• MalfunctionJul 5, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, THE ARTERIAL THERMISTOR ON THE OXYGENATOR DID NOT RECORD THE TEMPERATURE. THE USER FACILITY TESTED THE CABLE ON THE VENOUS THERMISTOR PORT AND IT RECORDED THE TEMPERATURE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8765266 ↗
• MalfunctionMay 8, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, THE ARTERIAL THERMISTOR ON THE OXYGENATOR DID NOT RECORD THE TEMPERATURE. THE USER FACILITY TESTED THE CABLE ON THE VENOUS THERMISTOR PORT AND IT RECORDED THE TEMPERATURE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592802 ↗
• MalfunctionMay 8, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, THE ARTERIAL THERMISTOR ON THE OXYGENATOR DID NOT RECORD THE TEMPERATURE. THE USER FACILITY TESTED THE CABLE ON THE VENOUS THERMISTOR PORT AND IT RECORDED THE TEMPERATURE. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592642 ↗
• MalfunctionMay 8, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, THE ARTERIAL THERMISTOR ON THE OXYGENATOR DID NOT RECORD THE TEMPERATURE. THE USER FACILITY TESTED THE CABLE ON THE VENOUS THERMISTOR PORT AND IT RECORDED THE TEMPERATURE. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592599 ↗
• MalfunctionMay 8, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, THE ARTERIAL THERMISTOR ON THE OXYGENATOR DID NOT RECORD THE TEMPERATURE. THE USER FACILITY TESTED THE CABLE ON THE VENOUS THERMISTOR PORT AND IT RECORDED THE TEMPERATURE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592586 ↗
• MalfunctionApr 30, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OUT OF BOX, THE RESERVOIR BLOOD OUT CAP WAS OFF AND WAS LOOSE IN THE TYVEK BAG. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8565280 ↗
• MalfunctionApr 30, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OUT OF BOX, THE RESERVOIR BLOOD OUT CAP WAS OFF AND WAS LOOSE IN THE TYVEK BAG. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8565256 ↗