Shiley 86447Recalls & reported problems
Covidien LP · Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30884522005733), received between Nov 9, 2018 and Mar 12, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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. 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
- Disconnection5
- Leak/Splash1
Patient problems
- Unintended Extubation5
- Extubate1
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE 15MM CONNECTORS OF THE ENDOTRACHEAL TUBES WOULD COME OFF 4-5 TIMES A WEEK ON A RANGE OF SIZES. THE PATIENT IMPACT INCLUDED EXTUBATING AND REINTUBATION.
Patient problems: Unintended Extubation
MAUDE report 21586665 ↗MalfunctionMar 12, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE 15MM CONNECTORS OF THE ENDOTRACHEAL TUBES WOULD COME OFF 4-5 TIMES A WEEK ON A RANGE OF SIZES. THE PATIENT IMPACT INCLUDED EXTUBATING AND REINTUBATION.
Patient problems: Unintended Extubation
MAUDE report 21586652 ↗MalfunctionMar 12, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE 15MM CONNECTORS OF THE ENDOTRACHEAL TUBES WOULD COME OFF 4-5 TIMES A WEEK ON A RANGE OF SIZES. THE PATIENT IMPACT INCLUDED EXTUBATING AND REINTUBATION.
Patient problems: Unintended Extubation
MAUDE report 21586642 ↗MalfunctionMar 12, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE 15 MM CONNECTORS OF THE ENDOTRACHEAL TUBES WOULD COME OFF 4-5 TIMES A WEEK ON A RANGE OF SIZES. THE PATIENT IMPACT INCLUDED EXTUBATING AND REINTUBATION.
Patient problems: Unintended Extubation
MAUDE report 21586616 ↗MalfunctionMar 12, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE 15MM CONNECTORS OF THE ENDOTRACHEAL TUBES WOULD COME OFF 4-5 TIMES A WEEK ON A RANGE OF SIZES. THE PATIENT IMPACT INCLUDED EXTUBATING AND REINTUBATION.
Patient problems: Unintended Extubation
MAUDE report 21586605 ↗InjuryNov 9, 2018Leak/Splash; Leak/Splash
THE BALLOON IN THE TUBE HAS POPPED DURING INTUBATION. THE PATIENT REQUIRED REINTUBATION.
Patient problems: Extubate; No Information
MAUDE report 8055698 ↗
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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