Shiley 3.5PCF (UDI 10884521103528)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521103528), received between Feb 7, 2022 and Jan 26, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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.

• MalfunctionJan 26, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT BALLOON WAS DEFORMED EVEN WHEN FILLED WITH AIR DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18591736 ↗
• InjuryFeb 16, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT NEEDS TO CHANGE THE TUBE EVERY 2 WEEKS. AN ISSUE WITH THE AIR IN THE CUFF SEEMS TO GET WORSE AS IT¿S LEFT IN. A COMPLICATION WITH SECRETION MANAGEMENT AND CUFF LEAK LEAD TO EARLY REMOVAL OF TRACHEOSTOMY TUBE AND RE-INSERTION OF A REPLACEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unintended Extubation

  MAUDE report 13546756 ↗
• InjuryFeb 16, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT (PREVIOUSLY ON THE UNCUFFED TUBE AS THE CUFF DID NOT GO DOWN TO 3.5) HAD ISSUES WITH SECRETIONS DUE TO A CUFF AND PILOT BALLOON ISSUE.

  Patient problems: Fluid Discharge

  MAUDE report 13543057 ↗
• MalfunctionFeb 16, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACH TUBE WAS NOT HOLDING ITS AIR IN THE CUFF, IT HAD TO BE REMOVED AFTER 2 WEEKS INSTEAD OF 29 DAYS. THIS WAS AN INTERRUPTION TO THE PATIENT CARE. DUE TO THE PILOT BALLOON NOT INDICATING WHETHER AIR WAS IN THE CUFF OR NOT, IT CAUSED SAFETY CONCERNS UPON REMOVING.

  Patient problems: Unintended Extubation

  MAUDE report 13542990 ↗
• MalfunctionFeb 7, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, A CUFF LEAK WAS OBSERVED. THE CUFF REQUIRED CONSTANT INFLATION TO REACH THE OPTIMUM PRESSURE. THE PATIENT RECEIVED ANOTHER TRACHY TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 13477166 ↗