CAPIOX®RX CX*RX05RERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350763495), received between Mar 22, 2019 and Aug 26, 2020 — classified as 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionAug 26, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT DURING OTHER PROCEDURE THE INVOLVED CAPIOX DEVICE WAS USED, THERE WAS SUB-OPTIMAL CO2 REMOVAL. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED 06AUG2020. EVENT OCCURRED WITH A PEDIATRICS PATIENT. THEY WERE HAVING TROUBLE BLOWING OFF THE CO2 DURING RE-WARMING. THE PATIENT WAS BROUGHT TO A DEEP HYPOTHERMIC STATE OF AROUND 18 DEG C FOR THE PROCEDURE AND THEN DURING REWARMING HAD TROUBLE BLOWING OFF CO2. PATIENT HCT = 32%, SWEEP WAS CLOSE TO 5L/MIN AND FLOW WAS MAXED AT 1.5L/MIN. THERE WAS NO PATIENT INJURY, THE PATIENT'S CONDITION WAS GOOD. THERE WAS NO DELAY WITH THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454066 ↗
• MalfunctionMar 22, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX OXYGENATOR PRESENTED A LEAKAGE DURING PRIMING. THERE WAS AN APPROXIMATE TWENTY-MINUTE DELAY ON CONTINUING THE PROCEDURE. THE PRODUCT WAS CHANGED OUT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8445500 ↗