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CAPIOX®RX CX*RX15RE30Recalls & reported problems

Terumo Corporation · RX15 · 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 04987350771032), received between Nov 18, 2016 and Apr 12, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

  • Break2

Patient problems

  • No Patient Involvement2

Recent adverse event reports

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

  • MalfunctionApr 12, 2017Break; Break

    THE USER FACILITY REPORTED DAMAGE TO THE CAPIOX DEVICE PRIOR TO PRIMING. FOLLOW UP COMMUNICATION FROM THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: THE VENOUS ENTRANCE TO OXYGENATOR WAS NOTED TO HAVE BEEN BROKEN; THE EVENT OCCURRED DURING CEC ASSEMBLING, PRIOR TO PRIMING; THE OXYGENATOR WAS CHANGED OUT TO ANOTHER CAPIOX RX15RE30 DEVICE; AND THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 6485686 ↗
  • MalfunctionNov 18, 2016Break; Break

    THE USER FACILITY REPORTED DAMAGE TO THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: UPON OPENING THE BOX IT WAS REPORTED THAT THE THREE-WAY KEYS WERE BROKEN; AND THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 6113889 ↗

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.