Shiley 125235Recalls & reported problems
Covidien LP · Endobronchial Tube Left with Carinal Hook;Endobronchial Suction Catheter;Endobronchial Tube Accessories · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884522008775), received between Jun 4, 2025 and Aug 3, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (5 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFFS OF THE BRONCHO CATHETER TUBES HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22696670 ↗MalfunctionAug 3, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUFFS OF THE BRONCHO CATHETER TUBES HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22696659 ↗MalfunctionJul 3, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT PRIOR TO USAGE, THREE DOUBLE LUMEN TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394982 ↗MalfunctionJul 3, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT PRIOR TO USAGE, THREE DOUBLE LUMEN TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394890 ↗MalfunctionJun 4, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT PRIOR TO USAGE, THREE DOUBLE-LUMEN TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22144762 ↗
Other TUBE, BRONCHIAL (W/WO CONNECTOR) devices
- Shiley 125037Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)1 death209 reports
- Shiley 125035Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)114 reports
- Shiley 126035Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)50 reports
- Mallinckrodt 125037Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)49 reports
- Mallinckrodt 126037Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)47 reports
- Shiley 125039Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)40 reports
- Shiley 126039Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)39 reports
- Shiley 125032Covidien LP · TUBE, BRONCHIAL (W/WO CONNECTOR)34 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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