Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RW40Recalls & reported problems
Terumo Cardiovascular Systems Corporation · Class 2
All models of Capiox RX Hollow Fiber Oxygenator with Hardshell Reservoir (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00699753450141), received between Mar 19, 2021 and May 4, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (3 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
Device problems
- Unable to Obtain Readings3
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2021Output Problem; Output Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE TEMPERATURE PROBE DID NOT READ THE TEMPERATURE. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11769782 ↗MalfunctionMar 19, 2021Unable to Obtain Readings; Unable to Obtain Readings
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE TEMPERATURE PROBE WAS NOT READING TEMPERATURES. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11525925 ↗MalfunctionMar 19, 2021Unable to Obtain Readings; Unable to Obtain Readings
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE TEMPERATURE PROBE WAS NOT READING TEMPERATURES. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11525879 ↗MalfunctionMar 19, 2021Unable to Obtain Readings; Unable to Obtain Readings
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE TEMP PROBE WAS NOT READING TEMPERATURES. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11525874 ↗
Other Oxygenator, Cardiopulmonary Bypass devices
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- HLS Set BEQ-HLS 5050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls4 reports
- NA HLS Set Advanced 5.0, Small Adult, BIOLINE CoatingMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS3 recalls0 reports
- A.M.G. PMP Sterile A.M.G. Module PMP NO T.P. SterileEurosets Srl · Oxygenator, Cardiopulmonary Bypass2 deaths106 reports
- CAPIOX®FX CX*FX25RWTerumo Corporation · Oxygenator, Cardiopulmonary Bypass2 deaths102 reports
- CAPIOX®RX CX*RX25RWTerumo Corporation · Oxygenator, Cardiopulmonary Bypass1 death102 reports
- QUADROX-i HMO 50000-USA #SQUADROX-i Small Adult, no FilterMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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