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CAPIOX®FX CX*FX15RE40Recalls & reported problems

Terumo Corporation · FX15 · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350701107), received between Jun 17, 2021 and Jun 28, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

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 Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 28, 2021Infusion or Flow Problem; Infusion or Flow Problem

    THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. AFTER INITIALIZATION EXTRACORPOREAL CIRCULATION WITH FX OXYGENATOR, THE PERFUSIONIST DETECTED THAT THE OXYGENATOR'S OXYGEN EXCHANGE CAPABILITY WAS LOST. AFTER CHANGING NEW FX OXYGENATOR, THE OPEN-HEART SURGERY CASE WAS DONE WELL WITH GOOD OXYGENATOR'S OXYGEN EXCHANGE CAPABILITY. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12073881 ↗
  • InjuryJun 17, 2021Infusion or Flow Problem; Infusion or Flow Problem

    THE USER FACILITY REPORTED THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. WHEN THE PATIENT STARTED DOING EXTRACORPOREAL CIRCULATION WITH FX OXYGENATOR (LOT: 191202K), THE PO2 WAS 74.2 MMHG. THE FLOW RATE WAS INCREASED 0.5 L/M AND PO2 IS 296.8. AND PO2 WAS SUDDENLY DROPPED TO 51.2 MMHG ONLY AT FLOW RATE 3 L/M. THE COLOR OF BLOOD IN OUTPUT OF OXYGENATOR WAS BLACK, AND HOSPITAL DECIDED TO CHANGE TO A NEW FX OXYGENATOR. THE PO2 RECOVERED AND REACHED 520.2 MMHG NEW FX OXYGENATOR. THE DOCTOR OBSERVED A BLUE COLOR OF ARTERIAL BLOOD IMMEDIATELY AFTER RUNNING PROCESS. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12015264 ↗

Other Oxygenator, Cardiopulmonary Bypass devices

All Oxygenator, Cardiopulmonary Bypass devices →

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