AVANOS 13223Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038132235), received between Nov 22, 2021 and Dec 7, 2021 — classified as 2 malfunctions.

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

• MalfunctionDec 7, 2021Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THERE WAS AN OVERNIGHT ENDOTRACHEAL TUBE CHANGE DUE TO A CUFF LEAK. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2021, THE EVENT OCCURRED "A FEW NIGHTS BEFORE" (B)(6) 2021. THE PATIENT HAD BEEN AGITATED AND WAS CHEWING ON THE TUBE, HOWEVER THERE WERE NO OBVIOUS SIGNS OF DAMAGE TO THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957388 ↗
• MalfunctionNov 22, 2021Failure to Deflate; Failure to Deflate

  PER ADDITIONAL INFORMATION RECEIVED 2021-NOV-25, THE REPORTED EVENT LED TO A RE-INTUBATION, AS THE CUFF COULD NOT BE INFLATED AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851482 ↗