Shiley 5CN70EDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521726208), received between Sep 18, 2023 and Apr 28, 2026 — 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.

• MalfunctionApr 28, 2026Use of Device Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF DID NOT INFLATE DURING THE PRE-USAGE INSPECTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023040 ↗
• MalfunctionMar 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY'S INNER CANNULA LEAKED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528282 ↗
• MalfunctionSep 18, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AIR WAS INSERTED INTO THE CUFF OF THE TRACHEOSTOMY TUBE, AND AN AIR LEAK OCCURRED AFTER A FEW DAYS FROM THE START OF USE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 17768968 ↗