Shiley 5.0PLCF (UDI 20884521779911)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884521779911), received between Nov 18, 2022 and Mar 25, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF NO LONGER INFLATES. THE TUBE WAS REPLACED.

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

  MAUDE report 24689161 ↗
• MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE HAD AN AIR LEAK DURING USE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22487703 ↗
• MalfunctionOct 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S FLANGE EYELET WAS FOUND SPLIT/BROKEN AFTER 12-13 DAYS OF PATIENT USE. HAD BEEN USING SOFT TRACHEOSTOMY TAPES IN PRECEDING DAYS BUT USUALLY USES BEAD CHAINS. THE TUBE WAS REPLACED AND WAS ADVISED NOT TO USE BEAD CHAINS.

  Patient problems: Unintended Extubation

  MAUDE report 20438439 ↗
• MalfunctionOct 3, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A CRACK FOUND NEAR THE CONNECTION BETWEEN THE INFLATION LINE AND TUBE OF THE TRACHEOSTOMY TUBE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20363545 ↗
• MalfunctionAug 23, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, A LOT OF CUFF LEAKAGE WAS NOTICED FROM THE DAY THAT THE TRACHEOSTOMY TUBE WAS USED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20056223 ↗
• MalfunctionJun 9, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF OF THE TRACHEOSTOMY TUBE HAD INFLATION AND DEFLATION ISSUES. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19495333 ↗
• MalfunctionMay 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBE TO INFLATION LINE START-UP AREA WAS DAMAGED DURING USE. THERE WAS NO PATIENT HARM. IT WAS OBSERVED THAT THE WAY THE INFLATION LINE WAS WRAPPED DURING PACKAGING WAS DIFFERENT FROM THE PREVIOUS TRACH, AND THAT THE AMOUNT OF ADHESIVE AT THE TUBE CONNECTION REGION HAS BEEN REDUCED.

  Patient problems: Unintended Extubation

  MAUDE report 19312047 ↗
• MalfunctionMay 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBE TO INFLATION LINE START-UP AREA WAS DAMAGED DURING USE. THERE WAS NO PATIENT HARM. IT WAS OBSERVED THAT THE WAY THE INFLATION LINE WAS WRAPPED DURING PACKAGING WAS DIFFERENT FROM THE PREVIOUS TRACH, AND THAT THE AMOUNT OF ADHESIVE AT THE TUBE CONNECTION REGION HAS BEEN REDUCED.

  Patient problems: Unintended Extubation

  MAUDE report 19311994 ↗
• MalfunctionMay 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBE TO INFLATION LINE START-UP AREA WAS DAMAGED DURING USE. THERE WAS NO PATIENT HARM. IT WAS OBSERVED THAT THE WAY THE INFLATION LINE WAS WRAPPED DURING PACKAGING WAS DIFFERENT FROM THE PREVIOUS TRACH, AND THAT THE AMOUNT OF ADHESIVE AT THE TUBE CONNECTION REGION HAS BEEN REDUCED.

  Patient problems: Unintended Extubation

  MAUDE report 19309804 ↗
• MalfunctionDec 21, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT LINE CONNECTION HAD DAMAGED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378240 ↗
• MalfunctionNov 30, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S PILOT LINE CRACKED DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243280 ↗
• MalfunctionOct 7, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACH'S CUFF DID NOT INFLATE DURING USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17892540 ↗
• MalfunctionAug 21, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACH TUBE'S CUFF HAD AN AIR LEAK DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17592786 ↗
• MalfunctionNov 18, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE BALLOON RUPTURED THAT REQUIRED REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 15829427 ↗