Shiley 126039Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10884522028974), received between Mar 12, 2020 and Jul 17, 2026 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (33 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25854083 ↗
• MalfunctionJan 22, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE BRONCO CATH TUBE'S CUFF WAS WAS INFLATED WITH A PRESSURE OF 25 CMH2O AND THERE ARE BUBBLES IN THE SALINE SOLUTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144343 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, BOTH DOUBLE LUMEN BRONCHIAL TUBE'S CUFF HAD LEAKAGE AFTER INFLATED TO A PRESSURE OF 25 CMH2O AND IMMERSED IN NORMAL SALINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570129 ↗
• MalfunctionAug 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER HAD AN AIR LEAK PRIOR TO USE. REPLACEMENT OF THE TUBE HAS BEEN DONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710273 ↗
• MalfunctionAug 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER HAD AN AIR LEAK PRIOR TO USE. REPLACEMENT OF THE TUBE HAS BEEN DONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710267 ↗
• MalfunctionAug 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE BRONCO CATHETER HAD AN AIR LEAK. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22710193 ↗
• MalfunctionJun 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, BOTH DOUBLE-LUMEN BRONCHIAL TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22362232 ↗
• MalfunctionJun 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, BOTH DOUBLE-LUMEN BRONCHIAL TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360935 ↗
• MalfunctionJun 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFFS OF THE TWO TRACHEOSTOMY TUBES HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294516 ↗
• MalfunctionJun 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFFS OF THE TWO TRACHEOSTOMY TUBES HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293184 ↗
• MalfunctionJun 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE 39FR BRONCO CATHETER HAD CUFF INFLATION AND DEFLATION ISSUE PRIOR TO USE. THE EVENT OCCURRED IN A HOSPITAL SETTING AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22232133 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, BOTH BRONCO CATHETER'S TRACHEAL CUFF HAD AIR LEAKS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205362 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, BOTH BRONCO CATHETER'S TRACHEAL CUFF HAD AIR LEAKS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205297 ↗
• MalfunctionJun 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFFS OF THE TWO ENDOTRACHEAL TUBES HAD CUFF INFLATION AND DEFLATION ISSUES. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22154348 ↗
• MalfunctionJun 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFFS OF THE TWO ENDOTRACHEAL TUBES HAD CUFF INFLATION AND DEFLATION ISSUES. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22154155 ↗
• MalfunctionJun 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153232 ↗
• MalfunctionJun 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE 39FR BRONCO CATHETER'S CUFF LEAKED DURING USE AT A HOSPITAL. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22145584 ↗
• MalfunctionJun 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE 39FR BRONCO CATHETER CUFF COULD NOT BE INFLATED THE EVENT OCCURRED AT A HOSPITAL DURING PATIENT USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22145565 ↗
• MalfunctionMay 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE DOUBLE-LUMEN TUBE'S CUFF DID NOT DEFLATE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22099886 ↗
• MalfunctionMay 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THREE BRONCO CATHETERS' CUFFS WERE LEAKING AIR PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078392 ↗
• MalfunctionMay 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THREE BRONCO CATHETERS' CUFFS WERE LEAKING AIR PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078174 ↗
• MalfunctionMay 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THREE BRONCO CATHETERS' CUFFS WERE LEAKING AIR PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078115 ↗
• MalfunctionMay 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A DOUBLE-LUMEN BRONCHIAL TUBE CUFF LEAKED AIR BEFORE USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073025 ↗
• MalfunctionMay 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER HAD A LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039025 ↗
• MalfunctionMay 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFFS OF THE BRONCO CATHETERS FOUND LEAKING BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013271 ↗