Skip to content

LMA AIRWAY MANAGEMENT IPN041107Recalls & reported problems

Teleflex Incorporated · LMA Unique™ (Silicone Cuff) Cuff Pilot™ Size 3 · Class 1

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05060112313578), received between Oct 24, 2017 and Jul 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Deflation Problem3
  • Contamination /Decontamination Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED THAT: "THIS LMA WAS INSERTED INTO THE PATIENT AND WAS QUICKLY REMOVED WHEN THE CAA NOTICED THAT THERE WAS A PIECE OF FRAGMENT INSIDE THE TUBE OF THE LMA. IT WAS REMOVED IMMEDIATELY AND NO HARM OR CONSEQUENCE WAS REPORTED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22505663 ↗
  • MalfunctionAug 13, 2021Deflation Problem; Deflation Problem

    IT WAS REPORTED THAT "DURING INFLATION TEST OF THE MASK PRIOR TO USE, IT WAS IMPOSSIBLE TO DEFLATE THE MASK". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12321137 ↗
  • MalfunctionAug 13, 2021Deflation Problem; Deflation Problem

    IT WAS REPORTED THAT "DURING INFLATION TEST OF THE MASK PRIOR TO USE, IT WAS IMPOSSIBLE TO DEFLATE THE MASK". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12321112 ↗
  • MalfunctionOct 24, 2017Deflation Problem

    CRNA WAS PREPARING FOR CASE AND LMA #3 WOULD NOT DEFLATE. CRNA OBTAINED ANOTHER LMA #3 WITH SAME RESULTS. COULD NOT DEFLATE LMA.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6971103 ↗

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.