LMA ATOMIZATION IPN048826Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 14026704613103), received between Mar 16, 2023 and Sep 20, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "THE NASAL PLUG WAS FOUND DETACHED 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 20265212 ↗
• MalfunctionMay 17, 2024Suction Failure; Suction Failure

  IT WAS REPORTED "THE MEDICAL AGENT COULD NOT BE ASPIRATED INTO THE SYRINGE DURING USE. THEREFORE, A NEW UNIT WAS USED INSTEAD. NO INJURY TO THE PATIENT OCCURRED." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340142 ↗
• MalfunctionMar 6, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT "THE DEVICE IS BROKEN". ADDITIONAL INFORMATION: THE DEVICE DETACHED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847782 ↗
• MalfunctionFeb 16, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT "NASAL PLUG MISSING ON THE DEVICE IN AN UNOPENED PACKAGING". THE ISSUE WAS IDENTIFIED IN THE WAREHOUSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719695 ↗
• MalfunctionFeb 12, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT "THE LIQUID DOES NOT COME OUT OF THE SYRINGE AND THE DEVICE CANNOT USED. MOREOVER, THE NASAL ADAPTOR BROKE". THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE. ASSOCIATED COMPLAINTS 3003898360-2024-00211 AND 3003898360-2024-00212.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683373 ↗
• MalfunctionFeb 8, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT "THE LIQUID DOES NOT COME OUT OF THE SYRINGE" THERE WAS NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668185 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED THAT "THE LIQUID DOES NOT COME OUT OF THE SYRINGE AND THE DEVICE CANNOT USED. MOREOVER, THE NASAL ADAPTOR BROKE". THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE. ASSOCIATED COMPLAINTS: 3003898360-2024-00212.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667258 ↗
• MalfunctionMar 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT "DETACHED PART FROM THE SYRINGE PLUNGER." THE CONDITION OF THE PATIENT WAS REPORTED AS "FINE". NO MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 16600306 ↗
• MalfunctionMar 23, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT "OPEN PRIMARY PACKAGING. THIS WAS NOTED ON 1 DEVICE." THIS OCCURRED DURING INVENTORY INSPECTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598827 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS USING THE DEVICE AT HOME AND IT BROKE DURING ITS FIRST USE. THE PATIENT COMPLETED THEIR TREATMENT BY USING ANOTHER DEVICE. NO MEDICAL INTERVENTION NEEDED. NO HARM OR INJURY TO THE PATIENT. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582305 ↗
• MalfunctionMar 16, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT "OPEN PRIMARY PACKAGING. THIS WAS NOTED ON 1 DEVICE." THIS OCCURRED DURING INVENTORY INSPECTION. NO PATIENT INV OLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553942 ↗