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Shiley 5-18537Recalls & reported problems

Covidien LP · Esophageal Tracheal Airway with X-Ray Line,Double Lumen. Manufactured under license of Frass and Frenzer. · Class 2

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 40884521105554), received between Nov 12, 2019 and Nov 12, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Gas/Air Leak2

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 12, 2019Gas/Air Leak; Gas/Air Leak

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD TWO SMALL BRONCHIAL INTUBATION WHITE SLEEVES THAT ARE LEAKING AND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 9312971 ↗
  • MalfunctionNov 12, 2019Gas/Air Leak; Gas/Air Leak

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD TWO SMALL BRONCHIAL INTUBATION WHITE SLEEVES THAT ARE LEAKING AND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 9310083 ↗

Other AIRWAY, ESOPHAGEAL (OBTURATOR) devices

All AIRWAY, ESOPHAGEAL (OBTURATOR) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.