Shiley 10CN10EDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521726253), received between Sep 7, 2022 and Mar 17, 2025 — classified as 3 malfunctions.

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

• MalfunctionMar 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE'S CUFF HAD A LEAK AFTER INTUBATION. THE TUBE WAS REPLACED WITH A SMALLER SIZE.

  Patient problems: Unintended Extubation

  MAUDE report 21627862 ↗
• MalfunctionSep 7, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF HAD AN INFLATION/DEFLATION ISSUE. THE CUFF WAS TESTED PRIOR TO USE WITH AN AUTOMATIC AND MANUAL CUFF TRUCK CONTROLLER AND THE CUFF PRESSURE WAS DETERMINED BY INFLATING THE CUFF UNDERWATER. THE PATIENT QUICKLY STABILIZED AFTER RE-CANNULATION.

  Patient problems: Unintended Extubation

  MAUDE report 15371843 ↗
• MalfunctionSep 7, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF HAD AN INFLATION/DEFLATION ISSUE. THE CUFF WAS TESTED PRIOR TO USE WITH AN AU TOMATIC AND MANUAL CUFF TRUCK CONTROLLER AND THE CUFF PRESSURE WAS DETERMINED BY INFLATING THE CUFF UNDERWATER. THE PATIENT QUICKLY STABILIZED AFTER RE-CANNULATION.

  Patient problems: Unintended Extubation

  MAUDE report 15371773 ↗