LMA AIRWAY MANAGEMENT IPN922810Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 15060112318082), received between Nov 10, 2021 and Oct 23, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "ON (B)(6) 2025, 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 23365695 ↗
• MalfunctionAug 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2025, 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 22794490 ↗
• MalfunctionMay 9, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897201 ↗
• MalfunctionMar 29, 2023Obstruction of Flow; Obstruction of Flow

  REPORTED ISSUE: THE DOCTOR FOUND TUBE BLOCKED WHEN USING IT ON THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED 31-MAR-2023: "THE DEVICE WASN'T PRE-TESTED, THE DEVICE WAS INSERTED IN THE PATIENT, THEN THE CLINICIAN CANNOT INSERT THE SUCTION TUBE THROUGH THE TUBE. THEN IMMEDIATELY CHANGED NEW ONE,NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16638039 ↗
• MalfunctionFeb 15, 2023Fitting Problem; Fitting Problem

  REPORTED EVENT: DURING A RESUSCITATION, A 50CC LUER-LOCK FAILED TO ATTACH TO THE LMA. A NEW LMA SIZE 3 WAS USED AND WAS ABLE TO ATTACH A 50CC LUER-LOCK. AFTER THE PROCEDURE ANOTHER DEVICE WAS TESTED WITH A LUER-LOCK 50CC AND THIS ALSO FAILED TO FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382679 ↗
• MalfunctionFeb 15, 2023Nonstandard Device; Nonstandard Device

  REPORTED EVENT: DURING A RESUSCITATION, A 50CC LUER-LOCK FAILED TO ATTACH TO THE LMA. A NEW LMA SIZE 3 WAS USED AND WAS ABLE TO ATTACH A 50CC LUER-LOCK. AFTER THE PROCEDURE ANOTHER DEVICE WAS TESTED WITH A LUER-LOCK 50CC AND THIS ALSO FAILED TO FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380437 ↗
• MalfunctionFeb 8, 2023Obstruction of Flow; Obstruction of Flow

  REPORTED EVENT: AFTER PLACEMENT THE USER WAS UNABLE TO INSERT A STOMACH TUBE THROUGH THE LMA. THEREFORE, THE LMA WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327011 ↗
• MalfunctionAug 9, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "THE DOCTOR FOUND TUBE BLOCK WHEN USING ON PATIENT AND CHANGED NEW ONE. NO IMPACT ON PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192796 ↗
• MalfunctionAug 2, 2022Leak/Splash; Leak/Splash

  COMPLAINT REPORTED THAT: "USING THE CVC THEY REALIZED IT WAS BROKEN. AFTER PLACING THE MASK ON THE PATIENT, THE MEDICAL PERSONNEL REALIZED THAT MASK HAD A LEAK IN THE BALLOON, THE NURSING PERSONNEL REMOVED THE MASK AND REQUESTED A DEVICE CHANGE. THE INCIDENT CAUSED A DELAY IN PATIENT CARE.

  Patient problems: Insufficient Information

  MAUDE report 15145206 ↗
• MalfunctionFeb 21, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR FOUND AIR LEAK WHILE INTUBATING PATIENT. NO INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13568702 ↗
• MalfunctionFeb 15, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534696 ↗
• 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 12787847 ↗
• 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 12787792 ↗
• 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 12787746 ↗
• 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 12787701 ↗
• 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 12787416 ↗
• 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 12787345 ↗
• 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 12787324 ↗
• 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 12787295 ↗
• 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 12787251 ↗
• 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 12787187 ↗