LMA AIRWAY MANAGEMENT IPN924140Recalls & reported problems
Teleflex Incorporated · LMA® Unique™ (Silicone Cuff) Airway with Cuff Pilot(TM) Technology Size 4 · Class 1
All models of LMA AIRWAY MANAGEMENT (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 15060112319287), received between Apr 10, 2025 and Jun 30, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deflate3
- Material Separation1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Material Separation; Separation Failure; Material Separation; Separation Failure
IT WAS REPORTED THAT: "WHILE REMOVING THE LMA POST OPERATIVELY BY ANESTHESIA, THE CLEAR TUBE SEPARATED FROM THE PINK AIRWAY PIECE. THIS WAS NOT DUE TO THE PATIENT BITING DOWN OR A DIFFICULT EXTUBATION. ANESTHESIA HAD TO RETRIEVE THE LEFT BEHIND AIRWAY PIECE FROM THE PATIENT'S THROAT. THE PATIENT HAD NO ADVERSE EFFECTS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357192 ↗MalfunctionApr 10, 2025Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT "IT WAS BROUGHT TO MY ATTENTION THAT WE HAVE HAD 4 DEVICES THAT WOULD NOT DEFLATE PRIOR TO USE. THE ISSUE WAS IDENTIFIED PRIOR TO USE." ASSOCIATED COMPLAINTS 3009307931-2025-00006, 3009307931-2025-00005 AND 3009307931-2025-00004.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21811959 ↗MalfunctionApr 10, 2025Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT "IT WAS BROUGHT TO MY ATTENTION THAT WE HAVE HAD 4 DEVICES THAT WOULD NOT DEFLATE PRIOR TO USE. THE ISSUE WAS IDENTIFIED PRIOR TO USE. ASSOCIATED COMPLAINTS 3009307931-2025-00006 AND 3009307931-2025-00004.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21811935 ↗MalfunctionApr 10, 2025Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT "IT WAS BROUGHT TO MY ATTENTION THAT WE HAVE HAD 4 DEVICES THAT WOULD NOT DEFLATE PRIOR TO USE. THE ISSUE WAS IDENTIFIED PRIOR TO USE." ASSOCIATED COMPLAINTS (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21811928 ↗
Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices
- Air-Q3® 50005Airlife · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- King LTS-D KLTSD420King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300015PMedline Industries, Inc. · 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 KLTSD421King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- ONE-PIECE GUEDEL AIRWAY, SIZE 3, ISO 9 1113090Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- KING LTS-D Kit KLTSD432King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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