Shiley 125237Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884522008785), received between Dec 11, 2019 and Jul 3, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (6 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 Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 22394856 ↗MalfunctionJun 11, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-INSPECTION TESTING, TWO ENDOBRONCHIAL TUBE'S CUFF HAD CUFF LEAKS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187537 ↗MalfunctionJun 11, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-INSPECTION TESTING, TWO ENDOBRONCHIAL TUBE'S CUFF HAD CUFF LEAKS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187479 ↗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 22144773 ↗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 22144731 ↗MalfunctionDec 11, 2019Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD CUFF THAT WON'T BLOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9454876 ↗
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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