Shiley 86446Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30884522005726), received between Sep 20, 2021 and Dec 19, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem5
- Appropriate Device Problem Term/Code Not Available1
- Defective Component1
Patient problems
- Unintended Extubation3
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE OF THE SIZE 5MM CURVED ENDOTRACHEAL TUBE, THE CUFF WAS OBSERVED TO BE POPPING WHILE IN THE TRACHEA. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23853516 ↗MalfunctionDec 12, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE TRACH TUBE'S CUFF WERE "RUPTURED" IN THE PATIENT'S TRACHEA. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23794160 ↗InjuryMar 5, 2024Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, FOR THE 5.00MM, IT WAS HARD FOR THE BALLOON TO PASS THROUGH THE VOCAL CHORDS BEFORE INFLATION, WHICH WAS REALLY DAMAGING TO THE CHORDS COMING BACK OUT AFTER DEFLATING.
Patient problems: Unspecified Tissue Injury
MAUDE report 18839793 ↗MalfunctionFeb 24, 2022Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF OF THE DEVICE WAS RUPTURED WHILE THE PATIENT WAS ASLEEP AFTER INTUBATION. THE TUBE CUFF WAS DEFLATED AND HAD TO BE REPLACED TO CONTINUE THE CASE. THERE WAS NO PATIENT HARM.
Patient problems: Unintended Extubation
MAUDE report 13593893 ↗MalfunctionSep 20, 2021Use of Device Problem; Defective Component; Use of Device Problem; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE WAS INSERTED AND INFLATED WHEN HEARD A POP. THE TUBE HAS BEEN REMOVED AND FOUND A HOLE IN THE CUFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12497406 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page