Shiley 4.0PCF (UDI 10884521103535)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521103535), received between Jun 9, 2023 and Jul 28, 2025 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A HOSPITAL PROCEDURE, THE CANNULA WAS NEW AND CHECKED BEFORE USE BY FILLING IT WITH 4ML OF AIR AND EMPTYING IT BACK. A MINI DROP OF OPTILUBE GEL WAS ADDED TO THE CANNULA AND WAS PLACED, THE MANDRAIN WAS REMOVED, VENTILATION WAS PLACED AND BALLOON WAS FILLED WITH 2ML OF AIR AND AFTER A SHORT PAUSE AGAIN WITH 2ML OF AIR, MAKING A TOTAL OF 4ML BUT A CUFF INFLATION/DEFLATION OCCURRED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22635606 ↗
• MalfunctionMay 28, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO USE, THE 4.0MM CANNULA'S CUFF WAS NOT THE NORMAL SHAPE. THE ISSUE WAS IDENTIFIED BEFORE REUSING THE CANNULA. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100449 ↗
• MalfunctionApr 5, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF WAS FOUND NOT INFLATED DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19055631 ↗
• MalfunctionApr 5, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE STOPPED INFLATING DURING USE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19050053 ↗
• MalfunctionApr 5, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE STOPPED INFLATING DURING USE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19049953 ↗
• MalfunctionFeb 9, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AIR WAS INSERTED INTO THE CUFF, BUT IT DID NOT COME IN. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 18680746 ↗
• InjuryJun 9, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT COMPLAINED OF PAIN WHEN INFLATING THE TRACH'S CUFF TO HAVE THE APPROPRIATE VENTILATION. AS THE CUSTOMER COULD NOT GET MORE TRACHES DUE TO BEING BACK-ORDERED, THE TRACH WAS REUSED AND CLEANED EVERY WEEK, BUT DURING THE SECOND WEEK OF USE, HIGH-PRESSURE ALARMS STARTED TO GO OFF, AND HAD TO DEFLATE AND RE-INFLATE THE TRACH ANYWHERE FROM TWO TO SIX TIMES A NIGHT; THUS PATIENT GETTING VERY LITTLE SLEEP. EVENTUALLY, AFTER ABOUT NINE OR TEN DAYS, THE CUFF BREAKS.

  Patient problems: Pain

  MAUDE report 17100726 ↗