LMA AIRWAY MANAGEMENT IPN922811Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15060112318099), received between Nov 10, 2021 and Sep 25, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (11 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR PERFORMED GENERAL ANESTHESIA INDUCTION ON THE PATIENT AND PREPARED TO INSERT A 4-INCH LARYNGEAL MASK THAT WAS NEWLY PACKAGED AND COATED WITH LIDOCAINE CREAM. AFTER REPEATED ADJUSTMENTS, THERE WAS STILL CUFF LEAKAGE. THE MASK WAS TAKEN OUT FOR INSPECTION AND IT WAS FOUND THAT THE FRONT END HAD PEELED OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144152 ↗
• MalfunctionDec 12, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. IT WAS CHANGED TO A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959081 ↗
• MalfunctionMay 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT"THE DOCTOR FOUND CUFF BROKEN WHEN OPENING THE PACKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14373570 ↗
• MalfunctionMar 9, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AIR LEAKED FROM THE DEVICE DURING USE ON A PATIENT. THEREFORE, IT WAS REPLACED WITH A NEW UNIT". SPECIFIC INFORMATION REGARDING THE LEAK WAS NOT AVAILABLE. NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710094 ↗
• MalfunctionJan 4, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "NURSE FOUND THERE WAS A LEAKAGE ON CUFF PRIOR TO USING TO PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151435 ↗
• MalfunctionDec 6, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT AND THEN CHANGED NEW ONE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12939324 ↗
• MalfunctionNov 10, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787638 ↗
• MalfunctionNov 10, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787555 ↗
• MalfunctionNov 10, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787512 ↗
• MalfunctionNov 10, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787462 ↗
• MalfunctionNov 10, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787063 ↗
• MalfunctionNov 10, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787015 ↗