Shiley 126035Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10884522028950), received between Apr 9, 2019 and Jun 24, 2026 — classified as 1 injury, 49 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. 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Use of Device Problem

  IT WAS REPORTED THAT WHEN THE ENDOBRONCHIAL TUBE'S TRACHEAL BALLOON WAS INFLATED, BUT IT DID NOT FULLY DEFLATE AT THE PROXIMAL LEVEL OF THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 25604457 ↗
• MalfunctionJun 23, 2026Use of Device Problem

  IT WAS REPORTED THAT WHEN THE ENDOBRONCHIAL TUBE'S TRACHEAL CUFF WAS DEFLATE, IT DID NOT FULLY DEFLATE AT THE PROXIMAL LEVEL OF THE PATIENT. THERE WERE TWO OTHER TUBES TESTED AND SHOWED THE SAME ISSUE. THERE WAS A DELAY IN INTUBATION BUT NO APPARENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25590694 ↗
• MalfunctionJun 23, 2026Use of Device Problem

  IT WAS REPORTED THAT WHEN THE ENDOBRONCHIAL TUBE'S TRACHEAL CUFF WAS DEFLATE, IT DID NOT FULLY DEFLATE AT THE PROXIMAL LEVEL OF THE PATIENT. THERE WERE TWO OTHER TUBES TESTED AND SHOWED THE SAME ISSUE. THERE WAS A DELAY IN INTUBATION BUT NO APPARENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25590689 ↗
• MalfunctionJun 5, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE; THE CUFFS OF THE TWO BRONCO CATHETERS HAD A BREAKAGE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 25409006 ↗
• MalfunctionApr 15, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE DOUBLE LUMEN TUBE'S TRACHEAL CUFF HAD AN INFLATION OR DEFLATION ISSUE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24884435 ↗
• MalfunctionApr 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER EXPERIENCED LEAK PRIOR TO USE IN THE HOSPITAL. THE TUBE WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866920 ↗
• MalfunctionApr 1, 2026Gas/Air Leak

  IT WAS REPORTED THAT INTRAOPERATIVELY, AFTER DOUBLE LUMEN TUBE INTUBATION, AIR LEAKAGE OF THE BRONCHIAL CUFF WAS IDENTIFIED WHEN THE PHYSICIAN ATTEMPTED TO INFLATE IT, RENDERING THE TUBE UNUSABLE. A BACKUP DEVICE WAS IMMEDIATELY PREPARED, THE PATIENT WAS RE-INTUBATED, AND VITAL SIGNS WERE CLOSELY MONITORED.

  Patient problems: Unintended Extubation

  MAUDE report 24755664 ↗
• MalfunctionJan 29, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PREOPERATIVE PREPARATION, MEDICAL STAFF CHECKED THE DOUBLE-LUMEN ENDOTRACHEAL TUBE AND FOUND THAT THEY COULD NOT EXTRACT THE AIR FROM THE CUFF, AND THE CUFF COULD NOT SHRINK. THE MEDICAL STAFF REPLACED THE TUBE WITH A NEW ONE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208743 ↗
• MalfunctionDec 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER HAD INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768150 ↗
• MalfunctionNov 6, 2025Crack; Crack

  IT WAS REPORTED THAT THE CUFF THE FIRST HAD A CRACK AND THE SECOND DEVICE HAD A HOLE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490274 ↗
• MalfunctionSep 16, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066711 ↗
• MalfunctionAug 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE THE CUFF COULD NOT BE INFLATED WHEN TESTED. THE EVENT OCCURRED IN A HOSPITAL SETTING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22863738 ↗
• MalfunctionAug 6, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS CUFF AIR LEAKAGE DURING THE INFLATION AND DEFLATION TEST WITH THE TWO BRONCO CATHETER AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730257 ↗
• MalfunctionJul 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE 35FR BRONCO CATHETER'S CUFF HAD A LEAK DURING USE IN A HOSPITAL SETTING. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22463014 ↗
• MalfunctionJul 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THAT CUFFS OF THE TWO BRONCO CATHETERS HAD AN AIR LEAKAGE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22448982 ↗
• MalfunctionMay 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, 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 22002046 ↗
• MalfunctionApr 1, 2025Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFFS OF THE THREE TRACHEOSTOMY TUBES AND TWO BRONCHO CATHETERS HAD AN AIR LEAK. THE FIRST TUBE HAD AN ISSUE AFTER INSERTION, WHEN THE ANESTHESIA MACHINE LEAKED AIR AND HAD AN ALARM, AFTER REMOVAL AND INFLATING, THE CUFF WAS FOUND TO BE LEAKING AIR. REPLACEMENT OF THE TUBE WAS DONE. THE OTHER DEVICES HAD AN ISSUE DURING THE TESTING WHEN THE CUFFS WAS FOUND TO DEFLATE WHEN INFLATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746470 ↗
• MalfunctionJan 28, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE INTERFACE OF THE DOUBLE-LUMEN TUBE OF THE BRONCHO CATHETER WAS LOOSE AND FELL OFF. THE ISSUE OCCURRED AT A HOSPITAL AND INVOLVED THE INTERFACE FOR CONNECTING THE VENTILATION BRANCH TO THE MAIN BRANCH PIPELINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252892 ↗
• MalfunctionNov 20, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO ENDOTRACHEAL TUBES AND FOUR BRONCHO CATHETERS HAD AN AIR LEAKAGE IN THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736589 ↗
• MalfunctionSep 27, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-INSPECTION, BOTH DOUBLE-LUMEN ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328121 ↗
• MalfunctionSep 27, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-INSPECTION, BOTH DOUBLE-LUMEN ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326786 ↗
• MalfunctionSep 27, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFFS OF THE TWO BRONCO CATHETERS HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323436 ↗
• MalfunctionSep 27, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFFS OF THE TWO BRONCO CATHETERS HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323385 ↗
• MalfunctionSep 24, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-INSPECTION, THE DOUBLE-LUMEN ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT IN VOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289573 ↗
• MalfunctionSep 24, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-INSPECTION, THE DOUBLE-LUMEN ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289569 ↗