LMA AIRWAY MANAGEMENT IPN922772Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15060112318181), received between Nov 30, 2022 and Jun 12, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT AS THE DOCTOR "WAS PLACING THE LMA IN THE PATIENT'S AIRWAY, THE SILICONE CUFF CAME APART FROM THE PLASTIC TUBE AND THEN GOT LODGED IN THE PATIENT'S AIRWAY. THE DOCTOR WAS ABLE TO PULL IT OUT SAFELY". ADDITIONAL INFORMATION STATES THAT THERE WAS NO PATIENT HARM OR INJURY, THE PATIENT STATUS IS REPORTED AS "FINE". THE PROCEDURE WAS COMPLETED WITH MINIMAL DELAY AND THE PATIENT DID NOT EXPERIENCE ANY OXYGEN DESATURATION. THE DEVICE WAS BRAND NEW WITH NO NOTICEABLE DAMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17109975 ↗
• InjuryJun 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE "LMA WAS INSERTED IN A NORMAL MANNER. [THE DOCTOR] NOTICED THE PATIENT'S ETC02 LEVELS DROPPING, ATTEMPTED TO REPOSITION LMA. AT THAT POINT THE TUBE DETACHED FROM THE CUFF. [THE DOCTOR] WAS ABLE TO REACH INTO THE PATIENT'S AIRWAY AND REMOVE THE CUFF WITH HIS FINGERS. REPLACED WITH ANOTHER LMA. NO NEGATIVE ISSUES WITH THE PATIENT, CASE CONTINUED AFTER THIS SHORT DELAY". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". THE USER "DID NOT HAVE ANY INDICATION OF DAMAGE TO THE TRACHEA" AND THAT DURING THE EVENT, THE PATIENT DESATURATED TO THE "LOW 90'S".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17109744 ↗
• MalfunctionMar 15, 2023Material Separation; Material Separation

  REPORTED ISSUE: STRING OF PLASTIC WAS NOTICED INSIDE THE PATIENT'S MOUTH AFTER THE LMA WAS INSERTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550086 ↗
• MalfunctionMar 15, 2023Material Separation; Material Separation

  REPORTED ISSUE: THE SIZE 4 LMA WAS USED ON A PATIENT AND THE STRING OF PLASTIC WAS NOTICED INSIDE THE PATIENT'S MOUTH AFTER THE LMA WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548174 ↗
• MalfunctionJan 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE DEVICE CAME APART WHILE IN THE PATIENT. IT WAS EASILY REMOVED BY HAND AND THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086405 ↗
• MalfunctionNov 30, 2022Deflation Problem; Deflation Problem

  REPORTED ISSUE: PRIOR TO USE ON PATIENT, WHILE TESTING THE LMA, THE PROVIDER WAS NOT ABLE TO DEFLATE THE LMA EVEN AFTER CHANGING THE SYRINGE USED 3 SEPARATE TIMES. THE REPORTED DEFECT WAS DETECTED PRIOR TO USE IN A CLINICAL SETTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890289 ↗