Shiley 125039 (UDI 10884521831575)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521831575), received between Apr 6, 2023 and Jul 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ATTEMPT TO ISOLATE THE LUNG USING THE DOUBLE LUMEN TUBE WAS UNSUCCESSFUL AND THE OXYGEN SATURATION DROPPED BRIEFLY TO 94% WITH TWO LUNGS. IT WAS REALIZED THAT THE CUFF OF THE ENDOBRONCHIAL TUBE HAD AN ISSUE AND WAS NOT HOLDING PRESSURE. THE DOUBLE LUMEN TUBE WAS CHANGED TO SMALLER SIZE AND NO DESATURATION WAS NOTED. THE CUFF WAS EXAMINED AND WAS FOUND LEAKING AT THE GLUE SEAL. A SMALL HOLE IN THE CUFF WAS ALSO NOTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17280745 ↗
• MalfunctionApr 6, 2023Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691376 ↗
• MalfunctionApr 6, 2023Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691347 ↗