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CAPIOX® HEMOCONCENTRATOR CX*HC05SRecalls & reported problems

Terumo Corporation · Class 2

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 04987350738332), received between Jan 22, 2021 and Jan 22, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Infusion or Flow Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

    THE USER FACILITY REPORTED RED TINGE ON THE HEMOCONCENTRATOR. THE EFFLUENT WAS CLEAR WHEN THE PERFUSIONIST PRIMED WITH BLOOD. AFTER SITTING FOR AN HOUR, HE NOTICED THE RED TINGE IN THE HEMOCONCENTRATOR. THE ISSUE WAS DISCOVERED DURING PRIME. THERE WAS NO DELAY TO SURGERY AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM AND NO BLOOD LOSS FROM PRODUCT MALFUNCTION. THE PRODUCT WAS NOT CHANGED OUT AND WAS USED THROUGHOUT THE CASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11216101 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.