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Mallinckrodt 96375Recalls & reported problems

Covidien LP · Nasal RAE Tracheal Tube with TaperGuard Cuff,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 10884521157477), received between Jun 12, 2018 and Jun 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1

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.

  • MalfunctionJun 12, 2018Material Puncture/Hole; Material Puncture/Hole

    ACCORDING TO THE REPORTER, THERE WAS A PINPOINT HOLE IN A PROXIMAL PORTION OF THE CUFF. IT WAS WHERE THE CUFF ATTACHES TO THE TUBE. THEY ALSO STATED IT WAS NOT THE MAIN BODY OF THE CUFF BALLOON AND IT WAS NOT A RESULT OF A TORN CUFF FROM THE INTUBATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

    Patient problems: No Information

    MAUDE report 7590933 ↗

Other Tube, tracheal (w/wo connector) devices

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

Sources and updates

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