AEROmini® 00884450229859Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450229859), received between Sep 24, 2020 and Sep 24, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Ejection Problem” (1 report).
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
Device problems
- Ejection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2020Ejection Problem
WENT TO DEPLOY AN AEROMINI FLEXIBLE STENT 14X15 AND THE STENT WOULD NOT DEPLOY. THE STENT WAS DEFECTIVE. DIAGNOSIS: BRONCHIAL FISTULA. PROCEDURE PERFORMED: BRONCHOSCOPY FLEXIBLE, HB STENT BRONCHIAL NOVATECH DUMON VIA RIGID BRONCHOSCOPY. PROCEDURE IN DETAIL "DECISION WAS MADE TO SUE 14X15 MM METAL WIRE STENT TO BE PLACED VIA FLEXIBLE BRONCHOSCOPE. A GUIDE WIRE WAS INTRODUCED THROUGH THE WORKING CHANNEL OF FLEXIBLE BRONCHOSCOPE. WITH FLUOROSCOPE POSITION OF METAL STENT TO BE PLACED WAS MARKED. FLEXIBLE BRONCHOSCOPE WAS REMOVED WHILE GUIDE WIRE WAS LEFT IN PLACE. A 14X16 MM METAL WIRE STENT WAS INTRODUCED OVER THE GUIDE WIRE AND POSITIONED IN ALREADY MARKED AREA. UNFORTUNATELY STENT WAS UNABLE TO BE DEPLOYED DUE TO FAULTY STENT. STENT AND GUIDE WIRE WAS REMOVED. A RIGID BRONCHOSCOPE WAS INTRODUCED INTO THE AIRWAY. ONCE VOCAL CORD WAS SEEN, ETT WAS REMOVED AND RIGID BRONCHOSCOPE WAS ADVANCED AND POSITIONED JUST ABOVE THE RIGHT MAIN STEM. PATIENT WAS CONNECTED TO THE VENTILATOR. A 16X40 MM DUMON STENT WAS LOADED AND INTRODUCED THROUGH THE RIGID BRONCHOSCOPE. SUBSEQUENTLY STENT WAS DEPLOYED IN THE RIGHT MAIN STEM. STENT WAS NOTED TO BE INCOMPLETELY DEPLOYED. A 12 MM BRONCHIAL BALLOON WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10579452 ↗
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- WALLSTENT® Endoprosthesis H965404130Boston Scientific Corporation · Prosthesis, tracheal, expandable11 reports
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- iCAST 85414Atrium Medical Corporation · Prosthesis, tracheal, expandable10 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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