LMA AIRWAY MANAGEMENT IPN902073Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05060112310829), received between Jan 11, 2024 and Oct 10, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW ONE.THE SECOND ONE ALSO FOUND CUFF LEAKAGE DURING USE. CHANGE THE THIRD ONE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINTS 3009307931-2025-00039 AND 3009307931-2025-00038.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265532 ↗
• MalfunctionOct 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW ONE. THE SECOND ONE ALSO FOUND CUFF LEAKAGE DURING USE. CHANGE THE THIRD ONE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINTS 3009307931-2025-00039 AND 3009307931-2025-00038.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265522 ↗
• MalfunctionMay 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: ON "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW ONE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113510 ↗
• MalfunctionMay 19, 2025Melted; Device Damaged Prior to Use; Melted; Device Damaged Prior to Use

  IT WAS REPORTED THAT: "THE CUFF WAS FOUND DAMAGED (APPEARED TO HAVE MELTED) UPON OPENING THE PACKAGE. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE ISSUE WAS IDENTIFIED PRIOR TO USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042388 ↗
• MalfunctionApr 16, 2025Leak/Splash; Leak/Splash

  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 21846826 ↗
• MalfunctionMar 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "THE ANESTHESIA MACHINE INDICATED GAS LEAKS THROUGHOUT THE SURGERY, DESPITE INFLATING THE CUFF AND REPOSITIONING THE LMA. AT THE END, IT WAS NOTICED AIR LEAKS THROUGH THE CUFF VALVE (TIRE TEST). THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534948 ↗
• MalfunctionOct 9, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "ON (B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW ONE. THE PATIENT WAS REPORTED AS FINE POST THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406096 ↗
• MalfunctionAug 26, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2024, THE NURSE GAVE THE PATIENT INTUBATION IN ACCORDANCE WITH THE DOCTOR'S INSTRUCTIONS, AND AFTER I INTUBATION, FOUND THAT THE AIR BAG IN THE SINGLE-USE DOUBLE-TUBE LARYNGEAL MASK LEAKED, IT WAS THEN REPLACED WITH A NEW SINGLE-USE DOUBLE-TUBE LARYNGEAL MASK." THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062727 ↗
• MalfunctionJul 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PAITENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826120 ↗
• MalfunctionJul 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826096 ↗
• MalfunctionMay 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "CUFF LEAK DURING USE ON PATIENT". ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: Insufficient Information

  MAUDE report 19297382 ↗
• MalfunctionMay 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "CUFF LEAK DURING USE ON PATIENT". ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: Insufficient Information

  MAUDE report 19297346 ↗
• MalfunctionMar 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. ADDITIONAL INFORMATION: THE PATIENT WAS REINTUBATED WITH A DIFFERENT DEVICE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT ON HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18910649 ↗
• MalfunctionJan 16, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: (B)(6) 2023, THE SURGERY REQUIRES THE INSERTION OF A LARYNGEAL MASK, WHICH IS DIFFICULT TO INSERT AND CAUSES AIR LEAKAGE DURING THE PROCESS. PATIENT REPORTED AS GOOD POST THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518023 ↗
• MalfunctionJan 11, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: (B)(6) 2023, AFTER PLACEMENT, THERE WAS AIR LEAKAGE, SOME GAS ENTERED THE STOMACH, AND THE CONDITION DID NOT IMPROVE AFTER MANUAL BREATHING FOR 2 MINUTES. AFTER PLACEMENT AGAIN, THERE WAS STILL AIR LEAKAGE. THE TRACHEAL INTUBATION WAS IMMEDIATELY REPLACED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493431 ↗