UNIVERSAL FLEX2®BREATHING CIRCUIT KNCF375-6121ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612649204840), received between May 25, 2017 and May 25, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 25, 2017Material Separation; Material Separation

  PATIENT'S CO2 BEGAN TO RISE AFTER INDUCTION OF ANESTHESIA. CLINICIAN BEGAN TREATMENT PROTOCOL FOR MALIGNANT HYPERTHERMIA (MH). PATIENT'S CO2 DID NOT RESPOND ADEQUATELY TO MH PROTOCOL, SO BREATHING CIRCUIT WAS REMOVED AND A BAG-VALVE-MASK WAS USED TO VENTILATE THE PATIENT AT WHICH TIME IT WAS DISCOVERED THAT THE INSPIRATORY (INNER) TUBE OF THE COAXIAL BREATHING CIRCUIT HAD DETACHED FROM INNER TUBE OF THE CUFF. PATIENT'S CO2 LEVELS IMPROVED AND PATIENT WAS TRANSFERRED TO THE ICU, AND LATER TRANSFERRED TO ANOTHER FACILITY WHERE SHE COULD BE EVALUATED BY A INTERVENTIONAL RADIOLOGIST FOR POSSIBLE DEEP VEIN THROMBOSIS IN HER ARM AS A RESULT OF THE MH THERAPY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 6590484 ↗