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Mallinckrodt 86553Recalls & reported problems

Covidien LP · Oral/Nasal Tracheal Tube Cuffed,Reinforced, Murphy Eye · Class 2

All models of Mallinckrodt (73)

Data updated Oct 18, 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 10884522043380), received between May 21, 2019 and May 21, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Inflation Problem1
  • Leak/Splash1

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 21, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

    ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE'S CUFF HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS LEAKAGE NOTED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8628681 ↗

Other Tube, tracheal (w/wo connector) devices

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

Sources and updates

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