Shiley 125035 (UDI 10884521831551)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521831551), received between Jun 23, 2023 and Nov 29, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PART OF THE BRONCO CATHETER'S CUFF WAS TORN WHEN ABOUT TO TEST THE TUBE AFTER THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18225649 ↗
• MalfunctionJun 23, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN THE ANESTHESIOLOGIST PERFORMED A CUFF TEST FOR A DISPOSABLE DOUBLE-LUMEN ENDOBRONCHIAL TUBE BEFORE ANESTHESIA, IT WAS FOUND THAT THE CUFF LEAKED AIR AFTER INFLATION. THEREFORE, A NEW DISPOSABLE DOUBLE-LUMEN ENDOBRONCHIAL TUBE WAS REPLACED AND A LEAK TEST WAS PERFORMED. AFTER FOUND NO AIR LEAKAGE, INTUBATION WAS PERFORMED UNDER GENERAL ANESTHESIA, AND THE PROCESS WENT SMOOTHLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195139 ↗