Shiley 10CN10HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521172371), received between Mar 2, 2022 and Jun 28, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 24, 2023Open, Classified

   A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

   Z-1357-2023 · Root cause: Component change control · FDA record ↗

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.

• MalfunctionJun 28, 2024Disconnection; Connection Problem; Disconnection; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CANNULA OF THE TRACHEOSTOMY TUBE WAS EASILY POPPED OFF FROM THE PATIENT'S CONNECTOR. RE-CANNULATION AND REPLACEMENT OF THE TUBE WAS NOT REQUIRED BECAUSE A TRACHEOSTOMY TIE WAS USED TO SECURE THE TUBE UNTIL THE NEXT ROUTINE TRACHEOSTOMY CHANGE WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633633 ↗
• MalfunctionApr 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF WAS LOSING VOLUME DURING PATIENT USE DUE TO DEFECTIVE PILOT BALLOON. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19109242 ↗
• MalfunctionMar 6, 2024Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD A PINPOINT HOLE WHICH CAUSED A LEAK. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18852873 ↗
• MalfunctionJul 12, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT SHOWED NO SIGNS OF REQUIRING A SPECIALTY TRACH (IE: XLT). THE CUFF WAS CHECKED AND TESTED USING A SLIP TIP SYRINGE ADDING 5 TO 7 CC OF AIR. THE CUFF INFLATED/DEFLATED DURING PRE-TEST. THEY STARTED WITH A SIZE 9 FLEX CUFFED TRACH AND PLACED ON A VENT. THERE WAS NO ISSUES INFLATING THE CUFF OR CUFF INTEGRITY. THE ISSUE WAS THAT THE CUFF WAS TOO SMALL FOR THE TRACHEA DESPITE BASING THEIR DECISION ON IBW AND NECK THICKNESS. THIS WAS PROBLEMATIC BECAUSE THEY STARTED WITH TWO OF OUR LARGEST SIZED TRACH'S AVAILABLE AND FOLLOWED ALL GUIDELINES. THE CUSTOMER WAS WORRIED THAT THE TAPER SHAPED CUFF WAS ONLY BENEFICIAL FOR A VERY SMALL PATIENT COHORT WHICH MAY NOT BE A FEASIBLE LONG TERM SOLUTION. THE PATIENT HAD A LEAK AND HAD TO INPUT AN XLT.

  Patient problems: Unintended Extubation

  MAUDE report 14992005 ↗
• MalfunctionMay 19, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT HAD A RECENT EMERGENCY TRACHEOSTOMY CHANGE DUE TO MALFUNCTION. PATIENT WAS NOTED WITH NO RETURN TIDAL VOLUMES ON THE VENTILATOR, RCP ATTEMPTED TO RE-INFLATE THE PILOT BALLOON BUT WAS UNSUCCESSFUL. EMERGENCY TUBE REPLACEMENT WAS PERFORMED. THE PATIENT WAS CHANGED FROM A SIZE 10 TUBE TO A XLT8. TRACHEOSTOMY TUBE WAS KEPT AND WAS SUBMERGED IN THE WATER. THE PILOT BALLOON HAD A NOTICEABLE AIR BUBBLES.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 14437478 ↗
• MalfunctionApr 12, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS RUPTURED. AUDIBLE LEAK WAS NOTED AFTER INITIAL PLACEMENT WITH NO VOLUMES ON THE VENTILATOR. REPLACEMENT OF THE TRACH WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 14085504 ↗
• MalfunctionMar 2, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN AIR LEAK AND REQUIRED PROGRESSIVELY MORE AIR INTRODUCTION UP TO 45CM PRESSURE IN THE CUFF TO ELIMINATE THE ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653930 ↗