Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. 3CX*FX15RE30Recalls & reported problems
Terumo Cardiovascular Systems Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00699753450448), received between Mar 8, 2019 and May 8, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Coagulation in Device or Device Ingredient1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2023Break; Break
TEMP PROBE BROKEN OFF THE VENOUS INLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16888978 ↗MalfunctionDec 30, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
NEW INFORMATION RECEIVED INDICATING THAT THE CUSTOMER CONFIRMED THROUGH THEIR LAB THAT THE BUILD-UP POST FILTER WAS PRIMARILY PLATELETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13119030 ↗MalfunctionMar 8, 2019Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME A LEAK WAS NOTED. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Patient Involvement
MAUDE report 8405635 ↗
Other Oxygenator, Cardiopulmonary Bypass devices
- HLS Set BEQ-HLS 7050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls13 deaths90 reports
- Affinity Fusion® BB811Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls90 reports
- 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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