LMA ATOMIZATION IPN915310Recalls & reported problems
Teleflex Incorporated · MADgic Atomizer without Syringe · Class 2
All models of LMA ATOMIZATION (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704709882), received between Apr 8, 2026 and Aug 7, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173122 ↗InjuryApr 8, 2026Material Separation
IT WAS REPORTED THAT: "THE DEVICE TIP FELL OUT INTO A PATIENTS AIRWAY. IT WAS RETRIEVED BY A BRONCOSCOPE. THE PATIENT WAS NOT HARMED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815495 ↗
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 · TerminatedLMA(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 · TerminatedLMA 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 · TerminatedFLEXI 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
Other APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA devices
- LMA ATOMIZATION IPN048838Teleflex Incorporated · APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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