Shiley 86135Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521581920), received between Jan 3, 2025 and Aug 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2026Use of Device Problem

  It was reported that the endotracheal tube's cuff failed to inflate in a hospital setting. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184637 ↗
• MalfunctionDec 16, 2025Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE NURSE OPENED THE ENDOTRACHEAL TUBE PACKAGING, THE ENDOTRACHEAL TUBE WAS BROKEN IN TWO SECTIONS, AND REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824687 ↗
• MalfunctionDec 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS FOUND BROKEN INTO TWO SECTIONS AND WAS UNUSABLE WHEN A NURSE OPENED THE PACKAGING AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735238 ↗
• MalfunctionNov 3, 2025Use of Device Problem; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S PILOT LINE WAS CUT OFF BEFORE USE. THE UNIT REMAINED IN ITS PACKAGE AND HAD NOT UNDERGONE ANY CLEANING. THE ISSUE WAS IDENTIFIED AT THE HOSPITAL, AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452031 ↗
• MalfunctionJan 3, 2025Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE ENDOTRACHEAL TUBE HAD A LEAK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21068433 ↗