Shiley 125035 (UDI 40884522008731)Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 40884522008731), received between Jan 17, 2018 and Sep 15, 2026 — classified as 8 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (66 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Use of Device Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782167 ↗
• MalfunctionJul 31, 2026Gas/Air Leak

  It was reported that during patient use of the double-lumen endotracheal tube, air leakage occurred from the cuff. The tube was replaced.

  Patient problems: Unintended Extubation

  MAUDE report 50107940 ↗
• MalfunctionJul 30, 2026Gas/Air Leak

  It was reported that during use, the double lumen endotracheal tube's bronchial cuff had an air leak. The tube was replaced.

  Patient problems: Unintended Extubation

  MAUDE report 50085610 ↗
• MalfunctionJun 9, 2026Use of Device Problem

  IT WAS REPORTED THAT A CUFF INFLATION AND DEFLATION ISSUE INVOLVING A BRONCHOSCOPY CATHETER WAS IDENTIFIED PRIOR TO USE. THE ISSUE WAS REPORTED TO HAVE TAKEN PLACE IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451098 ↗
• MalfunctionJun 9, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE CUFF OF THE BRONCO CATHETER HAD A LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445868 ↗
• 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 25409047 ↗
• MalfunctionApr 27, 2026Use of Device Problem

  IT WAS REPORTED THAT THE BRONCO CATHETER WAS ASSOCIATED WITH A CUFF INFLATION ISSUE AND A CUFF DEFLATION ISSUE AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009701 ↗
• MalfunctionApr 27, 2026Use of Device Problem

  IT WAS REPORTED THAT THE BRONCO CATHETER WAS ASSOCIATED WITH A CUFF INFLATION ISSUE AND A CUFF DEFLATION ISSUE AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009699 ↗
• MalfunctionApr 27, 2026Use of Device Problem

  IT WAS REPORTED THAT THE BRONCO CATHETER WAS ASSOCIATED WITH A CUFF INFLATION ISSUE AND A CUFF DEFLATION ISSUE AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009689 ↗
• MalfunctionMar 17, 2026Use of Device Problem

  IT WAS REPORTED THAT THE BRONCO CATHETER'S WHITE CUFF WOULD NOT INFLATE DURING TESTING AS SHOWN FROM THE VIDEO PROVIDED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622234 ↗
• MalfunctionMar 6, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE DOUBLE LUMEN TUBE'S CUFF HAD AN INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532272 ↗
• MalfunctionFeb 23, 2026Use of Device Problem

  IT WAS REPORTED THAT THE BRONCO CATHETER EXPERIENCED A CUFF INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422583 ↗
• MalfunctionFeb 20, 2026Use of Device Problem

  IT WAS REPORTED THAT AFTER UNPACKING, THE CUFF OF THE BRONCO CATHETER HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399717 ↗
• MalfunctionFeb 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT CONNECTOR AIR LEAKAGE WAS IDENTIFIED WITH THE BRONCO CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24299026 ↗
• MalfunctionDec 4, 2025Crack; Crack

  IT WAS REPORTED THAT PRIOR TO USAGE, THE CONNECTOR OF THE DOUBLE LUMEN TUBE WAS FOUND DAMAGED AFTER OPENING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715240 ↗
• MalfunctionDec 2, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE DOUBLE LUMEN TUBE'S CUFF DID NOT INFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693898 ↗
• MalfunctionNov 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE DOUBLE LUMEN TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450170 ↗
• MalfunctionAug 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THREE DOUBLE-LUMEN AND AN ENDOTRACHEAL TUBE'S CUFF EACH HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815976 ↗
• MalfunctionJul 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAK. THE TUBE WAS REPLACED WITHOUT FURTHER IMPACT.

  Patient problems: Unintended Extubation

  MAUDE report 22573800 ↗
• MalfunctionJul 16, 2025Installation-Related Problem; Installation-Related Problem

  IT WAS REPORTED THAT THE TUBE WAS USUALLY USED IN THE COMBINATION OF OTHER DEVICE WITH NO PARTICULAR PROBLEM, BUT WHEN IT WAS USED, THE INSERTION RESISTANCE WAS FELT MORE THAN USUAL. THE TUBE WAS REPLACED.

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

  MAUDE report 22523543 ↗
• MalfunctionJul 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE DOUBLE-LUMEN TUBE'S BRONCHIAL CUFF DID NOT INFLATE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 22522446 ↗
• MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER DID NOT BALLOON. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Insufficient Information

  MAUDE report 22487736 ↗
• MalfunctionMay 14, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE 35FR BRONCO CATHETER, THERE WAS AN AIR LEAK ON THE BLUE CUFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019526 ↗
• MalfunctionMay 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, THE DOUBLE LUMEN TRACHEAL TUBE'S CUFF HAD AN AIR LEAK, AS SHOWN IN THE IMAGE ATTACHED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012128 ↗
• MalfunctionApr 25, 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 21910123 ↗