LMA AIRWAY MANAGEMENT IPN917164Recalls & reported problems
Teleflex Incorporated · LMA® Supreme™ 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15060112319935), received between Dec 11, 2025 and Mar 23, 2026 — classified as 5 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
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Gas/Air Leak
IT WAS REPORTED THAT"(B)(6) 2026, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. TUBE REMOVED AND CHANGED TO A NEW ONE. PATIENT IS REPORTED AS FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660637 ↗MalfunctionFeb 12, 2026Leak/Splash
IT WAS REPORTED THAT: "(B)(6) 2026, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320528 ↗MalfunctionJan 16, 2026Gas/Air Leak
IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE. THE PATIENT WAS REPORTED AS FINE. THERE WAS NO REPORTED HARM OR CONSEQUENCE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092906 ↗MalfunctionJan 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE. IT DID NOT AFFECT THE PROGRESS OF THE SURGERY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092076 ↗MalfunctionDec 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776503 ↗
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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