Shiley 126037Recalls & reported problems
Covidien LP · Endobronchial Suction Catheters with Color Coded Connectors; Endobronchial Tube; Endobronchial Tube Accessories,Right,(2) Right Angle Swivel Connectors; Carlens Y Adapter · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521831780), received between Nov 29, 2023 and May 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 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 DURING INSPECTION AND TESTING, THE CUFF OF THE BRONCO CATHETER WAS BROKEN AND HAD AN AIR LEAK AS SHOWN IN THE ATTACHED VIDEO. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003016 ↗MalfunctionNov 29, 2023Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, THE BRONCO CATHETER'S CUFF HAD AN INFLATION OR DEFLATION ISSUE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18231615 ↗
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
- Mallinckrodt 125035Covidien 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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