AVANOS 35167Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038351674), received between Feb 18, 2022 and Mar 10, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMar 10, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "WHILE ATTEMPTING TO PASS A BRONCHOSCOPY TO LOOK FOR OBSTRUCTIONS DUE TO THE DECLINE IN THE PATIENT'S O2 (OXYGEN) LEVELS, THE ETT [ENDOTRACHEAL TUBE] WAS NOTED TO BE KINKED." IT WAS NOTED THAT THE PATIENT'S O2 LEVEL WAS 97% UPON ADMISSION TO THE HOSPITAL, BUT THEN DROPPED TO THE LOW 90S. THE ETT WAS REPLACED AND THE PATIENT'S O2 LEVEL INCREASED TO THE HIGH 90S. THE PATIENT WAS DISCHARGED FROM THE ICU IN STABLE CONDITION. NO FURTHER COMPLICATIONS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13725331 ↗
• MalfunctionFeb 18, 2022Material Twisted/Bent

  WHILE ATTEMPTING TO PASS A BRONCHOSCOPY TO LOOK FOR OBSTRUCTIONS DUE TO THE DECLINE IN THE PATIENT'S O2 LEVELS, THE ETT WAS NOTED TO BE KINKED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13558731 ↗