Shiley 87440Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521816299), received between Mar 12, 2025 and Sep 18, 2026 — classified as 4 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.

• MalfunctionSep 18, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 50829675 ↗
• MalfunctionJun 4, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, FOUR ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399679 ↗
• MalfunctionMar 24, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, EVEN AFTER PRESSURE WAS APPLIED IN THE CUFF OF THE ENDOTRACHEAL TUBE, IT DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678314 ↗
• MalfunctionMar 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN AIR ENTERED AND EXPANDS THE ENDOTRACHEAL TUBE'S CUFF, IT QUICKLY DEFLATES. WHEN SUBMERGED IN WATER, AIR BUBBLES CAME OUT FROM THE INFLATION LINE AND TUBE JOINT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583467 ↗