UNIVERSAL FLEX2®BREATHING CIRCUIT KNCF370-6121ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00612649204826), received between Mar 17, 2017 and Sep 8, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Misassembled” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2017Occlusion Within Device; Occlusion Within Device

  PER COMPLAINANT, "THE CUSTOMER IS REPORTING THAT SOMETHING CAUSED THE HME PART TO GET SATURATED AND IT CAUSED BACK PRESSURE. THE NEGATIVE PRESSURE WHEN THE FILTER WAS TAKEN OFF AND THEY HAD TO VENTILATE THE PATIENT. DOCTOR IS REPORTING THIS CAUSED THE PATIENT TO GET PULMONARY EDEMA."

  Patient problems: Pulmonary Edema

  MAUDE report 6851881 ↗
• MalfunctionMar 17, 2017Misassembled; Misassembled

  PATIENT'S SAT LEVEL FELL. THE CLINICIANS BEGAN TROUBLESHOOTING, DURING WHICH TIME THE PATIENT WAS MANUALLY VENTILATED. IT WAS DISCOVERED THAT THE INNER HOSE AT THE MACHINE END OF THE BREATHING CIRCUIT WAS SEPARATED FROM THE BREATHING FILTER. THE BREATHING CIRCUIT WAS REPLACED AND PATIENT OUTCOME WAS UNAFFECTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 6412770 ↗