Shiley 87485Recalls & reported problems
Covidien LP · Oral/Nasal Endotracheal Tube, Intermediate Cuff Non DEHP · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521815292), received between Dec 12, 2024 and Sep 11, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (4 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 Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unintended Extubation2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT, DURING PRE-USE TESTING OF THE ENDOTRACHEAL TUBE, AIR COULD BE PUSHED INTO THE CUFF BUT THE CUFF COULD NOT BE DEFLATED. WHEN TUBE WAS LEFT OVER FOR 2 DAYS. THE CUFF DEFLATED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030770 ↗MalfunctionDec 13, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S PILOT VALVE HAD ISSUES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20929462 ↗MalfunctionDec 13, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S PILOT VALVE HAD ISSUES. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20929212 ↗MalfunctionDec 12, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S PILOT VALVE HAD ISSUES. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 20912470 ↗
Other Tube, tracheal (w/wo connector) devices
- Shiley 18875Covidien LP · Tube, tracheal (w/wo connector)4 deaths570 reports
- RUSCH IPN041476Teleflex Incorporated · Tube, tracheal (w/wo connector)10 recalls0 reports
- Shiley 18775Covidien LP · Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Covidien LP · Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 18880Covidien LP · Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 18780Covidien LP · Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770SCovidien LP · Tube, tracheal (w/wo connector)273 reports
- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 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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