Shiley 18755SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521620155), received between Feb 27, 2020 and Jul 31, 2026 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100750 ↗
• MalfunctionDec 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT IT APPEARED THAT THE PILOT BALLOON WAS DETACHED FROM THE INFLATION LINE BEFORE THE EXTUBATION. THE TUBE WAS NOT REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 23816762 ↗
• MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CUFF LEAK WAS IDENTIFIED WITH THE ENDOTRACHEAL TUBE DURING TEST BEFORE USE AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089531 ↗
• InjuryFeb 27, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE TUBE WAS KINKED. THE KINK WAS FOUND AT DEPTH MARKER AROUND 13CM. RE-INTUBATION WAS PERFORMED.

  Patient problems: Extubate

  MAUDE report 9762416 ↗