LMA AIRWAY MANAGEMENT IPN902076Recalls & reported problems
Teleflex Incorporated · LMA Supreme™ Size 5 · Class 1
All models of LMA AIRWAY MANAGEMENT (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060112310836), received between Jun 29, 2021 and Oct 6, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Deformation Due to Compressive Stress2
- Inflation Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Oxygen Saturation1
- Unintended Extubation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2022Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
IT WAS REPORTED THAT: "TUBE TO BLOW THE CUFF OD THE LARYNXMASK WAS BROKEN (KINK IN THE TUBE). THIS CAUSED DIFFICULTIES TO VENTILATE THE PATIENT. USES A NEW MASK, WAS FINE, BUT THIS TOOK EXTRA TIME AND DIFFICULTY TO VENTILATE PATIENT". THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS "FINE".
Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions
MAUDE report 15550939 ↗MalfunctionDec 7, 2021Inflation Problem; Inflation Problem
IT WAS REPORTED "CUFF INFLATION TUBING CRUSHED, UNABLE TO INFLATE CUFF. HAD TO REMOVE FROM PATIENT AND INSERT A NEW ONE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: Unintended Extubation
MAUDE report 12951656 ↗MalfunctionJun 29, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT "WHEN THE DOCTOR USED IT HE FOUND THE INFLATION LINE WAS KINKED AND THEREFORE THE VALVE WOULDN'T INFLATE. HE REMOVED THE MASK AND CHANGED TO AN IGEL". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12086484 ↗
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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