LMA AIRWAY MANAGEMENT IPN047898Recalls & reported problems
Teleflex Incorporated · LMA Protector™ Cuff Pilot™ 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060112313868), received between Apr 9, 2021 and Feb 3, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Airway Obstruction1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2022Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "CUFF LEAK WAS FOUND BEFORE USING. THE PATIENT, THE PRESSURE CANNOT BE CONTROLLED, AND THE PRESSURE WAS DECREASED". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446420 ↗MalfunctionApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED ""THE INSERTION OF THE LMA PROTECTOR WAS DIFFICULT, THE ANAESTHESIA WAS DEEPENED, THE LMA PROTECTOR WAS REMOVED FROM THE MOUTH AND A GUDEL TUBE WAS INSERTED FOR A LIGHT MASK VENTILATION. DURING THE INSERTION OF THE GUEDEL TUBE, A FOREIGN PART WAS DISCOVERED IN THE PATIENT'S THROAT. THIS PART, A SMALL PLASTIC RING WAS REMOVED OUT OF THE PATIENT'S THROAT. THIS RING IS USUALLY AT THE TIP OF THE LMA TUBE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: Airway Obstruction
MAUDE report 11740411 ↗MalfunctionApr 9, 2021Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "IT WAS FOUND BEFORE USING IT TO THE PATIENT. THERE WAS AIR LEAKING AT THE CUFF PILOT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641791 ↗
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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