LMA ATOMIZATION IPN048838Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704613219), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K153470); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED "THAT WHILE USING A MAD600 ON A PATIENT, IT BROKE OFF AND FELL INTO THEIR TRACHEA".

  Patient problems: Insufficient Information

  MAUDE report 12832170 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153470. One submission often covers many models, so check the product and lot details in each record.

• Z-3212-2017 · Jul 5, 2017 · Terminated
  LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to th
• Z-0384-2017 · Oct 27, 2016 · Terminated
  LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal,
• Z-0383-2017 · Oct 27, 2016 · Terminated
  FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex