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LMA IPN042417Recalls & reported problems

Teleflex Incorporated · LMA Fastrach™ SU ETT 8.0mm · Class 2

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 05060112310591), received between Jul 21, 2023 and Jul 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device 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 16, 2026.

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • Airway Obstruction1

Recent adverse event reports

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

  • MalfunctionJul 21, 2023Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT "PATIENT (60 YEARS OLD MALE) WAS PRONE FOR PROCEDURE WITH A REINFORCED TUBE IN SITU, NO CONCERNS ON INTUBATING, WHEN THEY WERE MOVING PATIENT FROM PRONE TO SUPINE, THE AIRWAY CAME OUT OF PATIENT, CAUSING AN AIRWAY OBSTRUCTION AND DIFFICULTY IN VENTILATING DESPITE THE BALLOON BEING INFLATED AS PER POLICY. THE PATIENT WAS VENTILATED AND REINTUBATED WITH ANOTHER ET TUBE, NO HARM CAME TO THE PATIENT." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: Airway Obstruction

    MAUDE report 17372288 ↗

Other Tube, tracheal (w/wo connector) devices

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

Sources and updates

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