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Shiley 86455Recalls & 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 60884522000784), received between Dec 10, 2019 and Dec 10, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

Most reported problems

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 10, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

    ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE'S CUFF WAS FOUND BROKEN. IT WAS INDICATED THAT THE CUFF AT THE FRONT OF THE CANNULA RUPTURED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 9448774 ↗

Other Tube, tracheal (w/wo connector) devices

All Tube, tracheal (w/wo connector) devices →

Sources and updates

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