Skip to content

LMA AIRWAY MANAGEMENT IPN922801Recalls & reported problems

Teleflex Incorporated · LMA Unique™ Size 4 · Class 1

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 15060112318037), received between Jul 21, 2023 and Jul 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Gas/Air Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJul 21, 2023Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "EXPERIENCED A PRESSURE LEAK, NOT GOOD ENOUGH SEAL TO MAINTAIN PROPER VENTILATION. THE LMA WAS REMOVED AS SOON AS DOCTOR EXPERIENCED THE LEAK IN THE SYSTEM, BEFORE DESATURATION. THEY REMOVED THE LMA AND INSERTED AN ETT. THEY WERE NOT MONITORING THE CUFF PRESSURE, BUT CONFIRMED AIR IN PILOT BALLOON." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17371783 ↗

Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices

All AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.