Shiley 125032 (UDI 10884521831544)Recalls & reported problems
Covidien LP · Endobronchial Suction Catheters with Color Coded Connectors; Endobronchial Tube, Left; Endobronchial Tube Accessories; (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 10884521831544), received between Jul 15, 2024 and Jul 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (1 report).
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
- Gas/Air Leak1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unintended Extubation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE FIRST BRONCO CATHETER WAS LACKING AN ADAPTER AND THE SECOND TUBE HAD A CUFF LEAK DURING USE. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22508360 ↗MalfunctionJul 15, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING TESTING, THE DOUBLE LUMEN ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19742417 ↗
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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