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LMA IPN922871Recalls & reported problems

Teleflex Incorporated · LMA Fastrach™ ETT 7.0mm · 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 15060112318778), received between May 12, 2023 and May 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionMay 12, 2023Break; Break

    IT WAS REPORTED THAT "THE [DOCTOR], DID AN AWAKE INTUBATION YESTERDAY, AND AFTER PLACING THE TUBE, THE INJECTION PORT ON THE PILOT TUBE TO THE CUFF, WAS FOUND TO HAVE A DEFECT". IT FURTHER STATES THAT "WE ARE USING THESE AS SINGLE USE (SINCE THE DISPOSABLE VERSION WAS DISCONTINUED) BUT THEY ARRIVE IN PACKAGING THAT SAYS 'AUTOCLAVE BEFORE USE', SO THEY HAVE ALL BEEN SENT TO BE STERILIZED BEFORE USE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Patient problems: Insufficient Information

    MAUDE report 16924148 ↗

Other Tube, tracheal (w/wo connector) devices

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

Sources and updates

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