Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RE30Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00699753450134), received between Mar 11, 2019 and Oct 18, 2019 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (15 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 1, 2023Open, Classified

   Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

   Z-1345-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE DEVICE DOES NOT REGISTER AN ARTERIAL TEMPERATURE. PER USER FACILITY THE TEMPERATURE CABLE REGISTERS A TEMPERATURE WHEN USED ON THE VENOUS TEMP PROBE BUT NOT ON THE ARTERIAL. 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 9210852 ↗
• MalfunctionAug 23, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT, DURING OTHER-NON CLINICAL ACTIVITY, THE ARTERIAL PROBE WAS FAULTY. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8926943 ↗
• MalfunctionAug 23, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE PROBE WAS FAULTY. 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 8926707 ↗
• MalfunctionAug 20, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE PROBE WAS FAULTY. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8910501 ↗
• MalfunctionAug 20, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL PROBE WAS FAULTY. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8910316 ↗
• MalfunctionAug 20, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE PROBE WAS FAULTY. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8910293 ↗
• MalfunctionAug 15, 2019Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  THE DISTRIBUTOR REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OUT OF BOX, THE RECEIVED CODE OF THE DEVICE WAS DIFFERENT FROM THE ONE REQUESTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8897815 ↗
• MalfunctionAug 9, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL PROBE WAS FAULTY. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8880790 ↗
• MalfunctionJul 31, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE FAULTY TEMPERATURE PROBE WAS UNABLE TO REGISTER A TEMPERATURE READING. AS PER THE USER FACILITY, THEY DID NOT CHANGE OUT THE PRODUCT; BYPASSED THE TEMPERATURE READING AND CONTINUED WITH THE SURGERY.   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 8848185 ↗
• MalfunctionMay 20, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL PROBE WAS UNABLE TO REGISTER A TEMPERATURE READING.   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 8625490 ↗
• MalfunctionMay 20, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE DEVICE WAS UNABLE TO REGISTER A TEMPERATURE READING. 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 8625112 ↗
• MalfunctionMar 19, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE PROBE PORTS WERE UNABLE TO RECORD TEMPERATURE. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8433617 ↗
• MalfunctionMar 11, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE PROBE PORTS WERE UNABLE TO RECORD TEMPERATURE.   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 8409696 ↗
• MalfunctionMar 11, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE PROBE PORTS WERE UNABLE TO RECORD TEMPERATURE. 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 8409603 ↗
• MalfunctionMar 11, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE PROBE PORTS WERE UNABLE TO RECORD TEMPERATURE.   NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT NOT CHANGED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409557 ↗
• MalfunctionMar 11, 2019Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL TEMPERATURE PROBE PORTS WERE UNABLE TO RECORD TEMPERATURE. 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 8409522 ↗