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Shiley 5-18437Recalls & reported problems

Covidien LP · Esophageal Tracheal Airway Rollup Lumen · Class 2

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 10884521211957), received between May 10, 2018 and May 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Inflation Problem1

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.

  • MalfunctionMay 10, 2018Inflation Problem; Inflation Problem

    ACCORDING TO THE REPORTER, WHEN THE UNIT WAS TAKEN OUT OF THE BOX AND INFLATED, THE MAIN BALLOON WAS NOTED TO LEAK AND HAD A SMALL HOLE IN IT.

    Patient problems: No Patient Involvement

    MAUDE report 7503496 ↗

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.