Shiley 86449Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30884522000455), received between Aug 9, 2024 and Jan 23, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE TRACH TUBE'S CUFF MADE POPPING NOISE AND THEN BLEW UPON INFLATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24166788 ↗
• InjuryAug 22, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN THE PATIENT WAS NOTED TO BE HAVING LOW TIDAL VOLUMES AND THE AIR WAS CHECKED, THERE WAS NO WAY TO VERIFY IT AS THE ENDOTRACHEAL TUBE'S PILOT BALLOON TIP WAS MISSING. THE TUBE WAS REPLACED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 20032740 ↗
• MalfunctionAug 9, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO ENDOTRACHEAL TUBES' PILOT BALLOON STRINGS SEEMED TO FALL OFF. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947862 ↗