LMA AIRWAY MANAGEMENT IPN922818Recalls & reported problems
Teleflex Incorporated · LMA Protector™ Cuff Pilot™ Size 5 · Class 1
- 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 15060112317993), received between Feb 3, 2022 and Mar 16, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash2
- Gas/Air Leak1
- Inflation Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2023Material Separation; Material Separation
REPORTED ISSUE: A RING CAME LOOSE AND GOT INSIDE THE PATIENT. ON THE RECOVERY THE PATIENT COUGHS IT UP. NO HARM OR INTERVENTION FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16550943 ↗MalfunctionApr 22, 2022Inflation Problem; Inflation Problem
IT WAS REPORTED THAT "CUFF PRESSURE VALVE STUCK IN RED BEFORE INFLATION. DEVICE "WAS REMOVED FROM PATIENT AND REPLACED WITH A NEW ONE." NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14190085 ↗MalfunctionFeb 9, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED "DR. PLACED SIZE 5, SEATED FINE AND WENT TO SQUEEZE BAG AND JUST INSUFFLATED STOMACH. TRIED AGAIN AND SAME THING HAPPENED. REPEATED THE PROCESS TWICE WITH A SIZE 4 AND SAME THING HAPPENED. ENDED UP INTUBATING PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: Insufficient Information
MAUDE report 13497690 ↗MalfunctionFeb 9, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED "DR. PLACED SIZE 5, SEATED FINE AND WENT TO SQUEEZE BAG AND JUST INSUFFLATED STOMACH. TRIED AGAIN AND SAME THING HAPPENED. REPEATED THE PROCESS TWICE WITH A SIZE 4 AND SAME THING HAPPENED. ENDED UP INTUBATING PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13497653 ↗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 13446468 ↗
Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices
- GUEDEL AIRWAY, SIZE 2, ISO 8 1112080Intersurgical Incorporated · 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 KLTSD422King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- GUEDEL AIRWAY, SIZE 000, ISO 3.5 1000035Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- Medline DYND300020PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300025PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300010PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.