AVANOS 13220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038132204), received between Apr 16, 2021 and Apr 16, 2021 — 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.

• MalfunctionApr 16, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CLINICIANS HEARD AIR AROUND THE CUFF WITH A NOTED POSSIBLE LEAK. THE DEVICE WAS REPLACED. ADDITIONAL INFORMATION RECEIVED 07-APR-2021 NOTED THE DEVICE WAS NOTED ALTERED IN ANY WAY PRIOR TO USE. THE DEVICE HAD BEEN IN USE FOR SEVEN DAYS WHEN PROBLEM WAS NOTED. THE CUFF WAS FILLED WITH 20CC OF AIR. THE PATIENT'S CURRENT STATUS AS IT RELATES TO THE REPORTED INCIDENT IS "UNKNOWN."

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 11682795 ↗