Shiley 125032 (UDI 40884522008724)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 40884522008724), received between Jul 30, 2018 and Jun 19, 2025 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (24 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290608 ↗
• 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. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746450 ↗
• MalfunctionMar 31, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729889 ↗
• MalfunctionJan 30, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO USAGE, THE BRONCO CATHETERS LINK PIPE JOINTS SIZE WERE FOUND NOT MATCHED, ONE OF THE ADAPTER JOINTS APPEARED TO BE SMALLER, AS SHOWN IN THE ATTACHED IMAGES. NEW TUBE WAS USED INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275578 ↗
• MalfunctionNov 26, 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 20784443 ↗
• MalfunctionNov 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DOUBLE-LUMEN BRONCHIAL TUBE'S CUFF "RUPTURED". THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20686269 ↗
• MalfunctionOct 4, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE BRONCO CATHETER'S TRACHEAL CUFF HAD AIR LEAK DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20378078 ↗
• MalfunctionSep 20, 2024Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE BRONCO CATHETER HAD A LEAK DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273835 ↗
• MalfunctionMay 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE OPENING PLACED IN THE "TRACHEAL BRANCH" (AN OPENING THAT LEADS TO THE RIGHT LUNG) WAS FRAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19395565 ↗
• MalfunctionMay 17, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF OF THE BRONCO CATHETER WAS DAMAGED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19345757 ↗
• MalfunctionMar 23, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE BRONCO CATHETER'S BLUE CUFF WAS FOUND LEAKING AIR AT THE TIP END DURING THE PROCEDURE. THE TUBE WAS REPLACED WITHOUT ANY PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 18966302 ↗
• MalfunctionFeb 28, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE BRONCO CATHETER'S BRONCHIAL CUFF DID NOT INFLATE DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799095 ↗
• MalfunctionFeb 6, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN AIR WAS INSERTED INTO THE BRONCO CATHETER'S AIR CUFF, THE BLUE CUFF ALSO INFLATED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18654629 ↗
• MalfunctionJan 16, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN AIR WAS INJECTED INTO THE INFLATION LINE OF THE BRONCHIAL CUFFS, THE BRONCHIAL CUFFS DID NOT INFLATE; WHEN AIR WAS INJECTED INTO THE INFLATION LINE OF THE ENDOTRACHEAL CUFFS, BOTH THE BRONCHIAL CUFF AND THE ENDOTRACHEAL CUFFS INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522637 ↗
• MalfunctionJan 12, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE BLUE CUFF OF THE BRONCO CATHETER HAD A LEAK AND HAD NOT BEEN IMPLANTED IN THE HUMAN BODY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503155 ↗
• MalfunctionJan 8, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TWO BRONCO CATHETERS HAD A HAIR AND A BLACK LINT INSIDE THE PACKAGING BAG. WHILE, THE OTHER BRONCO CATHETER CUFF'S WAS NOT INFLATING, ALL WERE FOUND DURING PREOPERATIVE EXAMINATIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469187 ↗
• MalfunctionOct 18, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE BLUE CUFF OF THE BRONCO CATHETER DID NOT INFLATE. WHEN THE WHITE CUFF WAS INFLATED, THE BLUE CUFF ALSO INFLATES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961494 ↗
• MalfunctionJul 17, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE BRONCHIAL CUFFS OF THE DOUBLE LUMEN TUBES HAD AN AIR LEAK DURING PRESSURE TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17335107 ↗
• MalfunctionJun 8, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE BRONCO CATH FAILED TO INFLATE DURING PRE-OP TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088602 ↗
• MalfunctionMar 23, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S BLUE CUFF HAD A LEAK DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600770 ↗
• MalfunctionAug 23, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS PRE-TESTED USING A SYRINGE WITH 25CM H2O AND A PRESSURE METER, CUFF DID NOT INFLATE /DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275606 ↗
• MalfunctionJun 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF WAS TESTED USING A SYRINGE 10CC, IT WAS FOUND THAT THE CUFF WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830048 ↗
• MalfunctionMar 15, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770543 ↗
• MalfunctionFeb 22, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD NO AIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582556 ↗
• MalfunctionJan 21, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314863 ↗