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Mallinckrodt 86397Recalls & reported problems

Covidien LP · Laser Oral Tracheal Tube Dual Cuffed,Murphy Eye · Class 2

All models of Mallinckrodt (73)

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 30884522002053), received between Nov 7, 2018 and Nov 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

  • Leak/Splash1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionNov 7, 2018Leak/Splash; Leak/Splash

    ACCORDING TO THE REPORTER, THE UNIT HAD LEAKED FROM THE DISTAL AREA WHERE THE RINGS END AND METAL PORTION THAT JOINS TO THE CUFFS. THE CUSTOMER ALSO STATED THAT BUBBLES COULD CLEARLY BE SEEN FROM THE JUNCTION. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

    Patient problems: No Information

    MAUDE report 8047386 ↗

Other Tube, tracheal (w/wo connector) devices

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

Sources and updates

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