Shiley 3.5NCF (UDI 10884521103474)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521103474), received between Feb 9, 2023 and Aug 1, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT'S PARENTS REGULARLY MANAGE THE CUFF PRESSURE BY A SYRINGE AT HOME. WHEN THE AIR INSIDE THE TRACH TUBE'S CUFF WAS REMOVED BY A SYRINGE DURING CUFF PRESSURE ADJUSTMENT, IT WAS RECOMMENDED TO INJECT 1.5 TO 2 CC AGAIN, BUT WHEN THE AIR INSIDE THE SYRINGE WAS THOUGHT COMPLETELY REMOVED, BECAUSE THE PATIENT COUGHED, THE AIR DID NOT COMPLETELY REMOVED, AND THE INJECTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689256 ↗
• MalfunctionFeb 9, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A MANUAL INSPECTION OF CANNULA, BEFORE INSERTION. AN AIR WAS INTRODUCED INTO THE CUFF THEN IMMERSED IN THE STERILE WATER. A LEAK FROM THE CUFF WAS REPORTED. ASKED FOR ANOTHER CANNULA. DURING INSPECTION IT WAS AGAIN FOUND OUT THAT THERE WAS A LEAK FROM THE CUFF. THE THIRD DEVICE EXPLODED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16337594 ↗