CAPIOX CX*RX05REARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350739025), received between Mar 6, 2025 and Mar 17, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Failure to Deliver” (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.

• MalfunctionMar 17, 2025Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE OXYGENATOR INVOLVED WAS DEFECTIVE. THERE EVENT DID NOT RESULT IN DELAY IN THE BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE OUT-FLOW CONNECTION UNDER RED CAPPED WAS BENT. THE PERFUSIONIST NOTED THE DEFECT DURING SETUP EXAMINATION, AND THE OXYGENATOR WAS NOT USED. THE PRODUCT WAS CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, AND NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621533 ↗
• DeathMar 6, 2025Failure to Deliver; Failure to Deliver

  THE USER FACILITY REPORTED THAT THE INVOLVED OXYGENATOR DID NOT FUNCTION PROPERLY. THE EVENT OCCURRED DURING CARDIOPULMONARY BYPASS. THE EVENT RESULTED IN DELAY IN BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. AFTER 3 HOURS AND 40 MINUTES THE DEVICE'S ABILITY TO OXYGENATE WAS NOT FUNCTIONING. SWEEP WAS AT 1.2 LPM AND 60% FIO2, PO2 WAS 295 THEN NEXT ENTRY FELL TO 95 AND CONTINUED FALLING DESPITE INCREASES IN FIO2 AND SWEEP. A SECOND OXYGENATOR WAS ADDED TO THE RECIRCULATION LINE TO FACILITATE OXYGENATION. THEY DID NOT CHANGE OUT THE OXYGENATOR THEY ADDED ANOTHER OXYGENATOR TO THE CIRCUIT TO FINISH THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO BLOOD LOSS WAS REPORTED. A DEATH OCCURRED. THE PATIENT DID NOT DIE IN SURGERY, THEY DIED IN INTENSE CARE UNIT (ICU).

  Patient problems: Insufficient Information

  MAUDE report 21536636 ↗