Skip to content

LMA AIRWAY MANAGEMENT IPN039839Recalls & reported problems

Teleflex Incorporated · LMA UNIQUE (SILICONE CUFF) SIZE 5 · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15060112315784), received between May 20, 2021 and May 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (2 reports).

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

  • Structural Problem2

Patient problems

  • Ecchymosis2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 20, 2021Structural Problem; Structural Problem

    IT WAS REPORTED "THE CHIEF OF ANESTHESIA INFORMED ME THAT TWO ENT DOCTORS SAID THAT THE TIP OF THE CUFF WAS CAUSING TRAUMA/BRUISING TO THE PATIENT'S EPIGLOTTIS". NO PATIENT DESATURATION REPORTED. NO MEDICAL INTERVENTION REQUIRED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: Ecchymosis

    MAUDE report 11858173 ↗
  • MalfunctionMay 20, 2021Structural Problem; Structural Problem

    IT WAS REPORTED "THE CHIEF OF ANESTHESIA INFORMED ME THAT TWO ENT DOCTORS SAID THAT THE TIP OF THE CUFF WAS CAUSING TRAUMA/BRUISING TO THE PATIENT'S EPIGLOTTIS". NO PATIENT DESATURATON REPORTED. NO MEDICAL INTERVENTION REQUIRED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: Ecchymosis

    MAUDE report 11858095 ↗

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.