Shiley 125037 (UDI 10884521831568)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521831568), received between Mar 17, 2023 and May 12, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A BRONCHIAL CUFF AIR LEAKAGE ASSOCIATED WITH THE BRONCO CATHETER. THE ISSUE OCCURRED AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002824 ↗
• MalfunctionMay 22, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-INSPECTION, IT WAS FOUND THAT THE BRONCHIAL CUFF OF THE DOUBLE-LUMEN ENDOTRACHEAL TUBE WAS LEAKING AND UNUSABLE. IT WAS REPLACED WITH A NEW SET OF TUBES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376614 ↗
• MalfunctionOct 16, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE BRONCO CATHETER'S CUFF HAD AN AIR LEAK DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940296 ↗
• MalfunctionApr 7, 2023Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704238 ↗
• MalfunctionApr 7, 2023Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702745 ↗
• InjuryMar 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, THE PATIENT UNDERWENT A RIGHT UPPER LOBECTOMY WITH VIDEO-ASSISTED THORACOSCOPIC SURGERY USING A 37 FR. LEFT-SIDED DOUBLE-LUMEN ENDOTRACHEAL TUBE (DLT) TO ACHIEVE ONE LUNG VENTILATION DURING THE PROCEDURE. INITIALLY, VENTILATION STATUS WAS STABLE WITH FREQUENT SUCTIONING OF OBSTRUCTIVE SPUTUM AND CONTINUAL POSITIVE AIRWAY PRESSURE. HOWEVER, THE PATIENT¿S BLOOD PRESSURE SUDDENLY DROPPED TO UNDER 50MMHG AND A CONTRALATERAL PNEUMOTHORAX WAS SUSPECTED. THE SURGICAL PROCEDURE WAS STOPPED TO ALLOW FOR PLACEMENT OF THE PATIENT IN THE SUPINE POSITION AND AN X-RAY CONFIRMED A TENSION PNEUMOTHORAX OF THE DEPENDENT LUNG. A CHEST TUBE WAS INSERTED IN THE LEFT CHEST AND THE PATIENT¿S CONDITION RAPIDLY IMPROVED. ALONG WITH BAROTRAUMA, THE FREQUEN T SUCTION OF SPUTUM AND HIGH PRESSURE VENTILATION HAD CONTRIBUTED TO THE CONTRALATERAL TENSION PNEUMOTHORAX. THE PROCEDURE WAS COMPLETED AND THE PATIENT RECOVERED WITHOUT ANY PERMANENT PATIENT INJURY.

  Patient problems: Low Blood Pressure/ Hypotension; Pneumothorax; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 16567778 ↗