Shiley 6.5PLCF (UDI 10884521103603)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521103603), received between Jul 16, 2021 and Sep 11, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE CUFF HAD A HOLE WHEN THE AIR WAS INSERTED DURING TESTING BEFORE INTUBATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023171 ↗
• MalfunctionMay 15, 2025Gas/Air Leak; Gas/Air Leak

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

  Patient problems: Unintended Extubation

  MAUDE report 22030813 ↗
• MalfunctionNov 19, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF "BURST" AFTER 48 HOURS OF BEING CHANGED WITH SIMILAR FAILURE. THE TRACH TUBE WAS REPLACED AGAIN.

  Patient problems: Unintended Extubation

  MAUDE report 20729392 ↗
• MalfunctionApr 22, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF PRESSURE WAS UNCONTROLLABLE DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154742 ↗
• MalfunctionApr 22, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF PRESSURE WAS UNCONTROLLABLE DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154682 ↗
• MalfunctionDec 19, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AFTER A FEW DAYS OF PATIENT USE, THERE WAS A CRACK FOUND IN TRACHEOSTOMY TUBE'S INFLATION LINE NEAR THE FLANGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359994 ↗
• MalfunctionSep 20, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, AIR ESCAPES FROM THE TRACHEOSTOMY TUBE'S CUFF AFTER A WEEK AND THERE WAS A CRACK NEAR THE FLANGE OF THE INFLATION LINE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17786215 ↗
• MalfunctionAug 16, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS MINIMAL LEAK OBSERVED FROM THE TRACH'S INFLATION LINE, CAUSING ISSUE WITH CUFF INFLATION/DEFLATION OF THE CUFF DURING USE TO A PATIENT. THERE WAS NO PATIENT HARM.

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

  MAUDE report 17561593 ↗
• MalfunctionFeb 25, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS A CUFF LEAK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600211 ↗
• MalfunctionJul 16, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO REPORTER, DURING PROCEDURE, THE CUFF WOULD NOT INFLATE PRIOR TO USE ON PATIENT. THE DEFECTIVE PRODUCT WAS NOT USE AND WAS REPLACED BY A NEW PRODUCT. THERE WAS NO PATIENT COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12185542 ↗