CAPIOX® HEMOCONCENTRATOR CX*HC11SRecalls & reported problems
Terumo Corporation · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350738394), received between Sep 19, 2016 and Feb 12, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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
- Complete Blockage1
- Filtration Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2020Filtration Problem; Filtration Problem
THE USER FACILITY REPORTED THAT DURING USE OF THE CAPIOX HEMOCONCENTRATOR DURING THE CPB CASE, THE PERFUSIONIST FOUND THE FILTRATE WAS RED, THE ACTUAL SAMPLE WAS CHANGED OUT WITH ANOTHER HC11S, AND THE SITUATION BECAME NORMAL. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9699307 ↗MalfunctionSep 19, 2016Complete Blockage; Complete Blockage
THE USER FACILITY REPORTED CLOGGING DURING THE USE OF A CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PERFUSIONIST CONNECTED THE HEMOCONCENTRATOR TO THE CPB; BLOOD WAS GOING THROUGH THE INLET BUT NOT COMING OUT OF THE OUTLET; THE FILTRATE WAS RED IN COLOR AND LESSER IN AMOUNT; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS NOT HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5960675 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.