Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. 3CX*FX15RW30Recalls & reported problems
Terumo Cardiovascular Systems Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753450745), received between Dec 23, 2019 and Dec 23, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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
- Infusion or Flow Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2019Infusion or Flow Problem; Infusion or Flow Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS AN IMPEDED VENOUS RETURN OF THE RESERVOIR. THE RESERVOIR WAS CAUSING BACK PRESSURE INTO THE VENOUS SIDE OF THE MANIFOLD. SUFFICIENT FLOW WAS ABLE TO BE MAINTAINED FOR THE PATIENT BUT WERE LIMITED TO 2.4 LPM. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9512110 ↗
Other Oxygenator, Cardiopulmonary Bypass devices
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- 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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