Shiley 125028Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 40884522008717), received between Jul 9, 2018 and Jun 30, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, THE DOUBLE-LUMEN BRONCHIAL TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360407 ↗
• 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 22290758 ↗
• 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 22290697 ↗
• 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 22290673 ↗
• 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 22290662 ↗
• 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 22290599 ↗
• MalfunctionJun 18, 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 22288682 ↗
• MalfunctionJun 18, 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 22288659 ↗
• MalfunctionJun 18, 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 22288646 ↗
• MalfunctionJun 18, 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 22288644 ↗
• MalfunctionJul 12, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE BRONCHIAL OF WHICH THE SUCTION TUBE IS BLUE IN THE PACKAGE PASSED THROUGH THE LUMEN, BUT THE TRACHEAL WAS STUCK NEAR 31CM OF THE TUBE. AND, ALSO THE SAME FOR THE FIBER FROM OLYMPUS, BRONCHIAL PASSED THROUGH THE LUMEN, BUT TRACHEAL WAS STUCK NEAR 31CM OF THE TUBE AND WAS NOT ABLE TO PASS. PATIENT WAS REINTUBATED. THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 14987907 ↗
• MalfunctionNov 19, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE TRACHEAL CUFF HAD A DEFLATION FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9343676 ↗
• MalfunctionNov 15, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE TRACHEAL CUFF HAD A DEFLATION FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9329639 ↗
• MalfunctionSep 26, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE TRACHEAL CUFF HAD A DEFLATION FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9122884 ↗
• MalfunctionJul 9, 2018Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING USE, THE FIBER ON TUBING LUMEN SIDE SEEMED TO BE STUCK IN. THE FACILITY OPERATE HYPERHIDROSIS SURGERY WITH THE PRODUCT MORE THAN 10 PAR MONTH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669469 ↗