AVANOS 35164Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038351643), received between May 20, 2024 and May 20, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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 16, 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 20, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, THE PATIENT WAS SCHEDULED TO UNDERGO AN ABRASION AND EYE AND HEARING EXAMINATION AND WAS PUT UNDER TOTAL INTRAVENOUS SEDATION IN THE EXISTING ¿PVK¿ AND RELAXED WITH ROCURONIUM. THE PATIENT WAS INTUBATED AND THE TUBE WAS CUFFED, CONFIRMED TO BE TIGHT AND CHECKED WITH A 2 ML SYRINGE; HOWEVER, THERE WAS NO RESULT ON THE CAPNOGRAPH AND THE DEVICE IMMEDIATELY WARNED OF A LEAKAGE. THE CUFF FILLING WAS CHECKED AND WAS FOUND TO BE COMPLETELY EMPTIED; THE TUBE WAS CUFFED (TWO MORE TIMES) AND LOST PRESSURE BOTH TIMES IN ABOUT 10 SECONDS. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH AN ORDINARY STRAIGHT TUBE OF THE SAME SIZE WITH SATISFACTORY RESULTS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350669 ↗