LMA AIRWAY MANAGEMENT IPN902070Recalls & reported problems
Teleflex Incorporated · LMA Supreme™ Size 3 · Class 1
All models of LMA AIRWAY MANAGEMENT (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05060112310812), received between Feb 22, 2021 and Nov 19, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak3
- Leak/Splash3
- Inflation Problem1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE". NO PATIENT HARM OR INJURY. THE PATIENT DID NOT DESATURATE DURING THE EVENT. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595647 ↗MalfunctionApr 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT: "ON (B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21863864 ↗MalfunctionMay 9, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT: "THERE WAS LEAKING FROM THE BALLOON WITH LMA SUPREME WHEN INTUBATATING THE PATIENT."
Patient problems: Insufficient Information
MAUDE report 19278054 ↗MalfunctionSep 30, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING USING ON THE PATIENT". NO HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12553702 ↗MalfunctionJun 23, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT "A HOLE WAS FOUND ON THE INFLATION TUBE DURING AN INFLATION TEST. THEREFORE, A NEW UNIT WAS OPENED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12053770 ↗MalfunctionJun 7, 2021Inflation Problem; Inflation Problem
IT WAS REPORTED ""CUFF ISSUE - UNABLE TO INFLATE CUFF". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11950578 ↗MalfunctionApr 5, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "THE AIR BAG WAS FOUND LEAKAGE DURING USING ON THE PATIENT". NO PATIENT HARM, INJURY, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11613198 ↗MalfunctionFeb 22, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "THE AIR BAG WAS FOUND LEAKAGE WHEN INFLATING BEFORE USE ON PATIENT". NO PAIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11362569 ↗
Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices
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- 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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