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
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
- GUEDEL AIRWAY, SIZE 2, ISO 8 1112080Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- KING LTS-D Kit KLTSD430King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300040PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- King LTS-D KLTSD422King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- GUEDEL AIRWAY, SIZE 000, ISO 3.5 1000035Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- Medline DYND300020PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300025PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300010PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.