LMA AIRWAY MANAGEMENT IPN901828Recalls & reported problems
Teleflex Incorporated · LMA Fastrach™ 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060112310423), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (1 report).
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 Leak1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "WE ORDERED A T5 AUTOCLAVABLE LMA FASTRACH MASK IN MARCH 2023 (PUT INTO SERVICE IN THE OPERATING ROOM IN JUNE 2023) WHICH HAS ONLY BEEN AUTOCLAVED 3 TIMES AND WHOSE BALLOON IS LEAKING.".
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18895003 ↗
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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