CAPIOX®RX CX*RX25WRecalls & reported problems
Terumo Corporation · RX25 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987350769534), received between Mar 10, 2017 and Mar 10, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2017Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE LEAKED 30 SECONDS PRIOR TO GOING ON CARDIOPULMONARY BYPASS. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION; THE PRODUCT WAS CHANGED OUT; AND BLOOD LOSS WAS REPORTED TO BE MINIMAL; AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Blood Loss
MAUDE report 6394713 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.