AERO® 00884450030844Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450030844), received between Nov 3, 2022 and Nov 3, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Granuloma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT A PATIENT HAD LOST CONSCIOUSNESS WHILE LYING FLAT, DURING A ROUTINE MEDICAL EXAMINATION. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. CT FINDINGS SHOWED 3 CM TUMOR OCCLUDING ALMOST OF THE PATIENT'S AIRWAY. A DEBULKING PROCEDURE WAS ACHIEVED, AND ENDOTRACHEAL INTUBATION WAS COMPLETED. THE PATHOLOGY FINDINGS SHOWED THE PATIENTS TUMOR WAS BENIGN. AN AERO STENT [2 X 4 CM] WAS PLACED WITHIN PATIENT'S TRACHEA TO COVER THE TUMOR. AFTER THE PLACEMENT OF THE STENT, EXTUBATING WAS ACHIEVED, AND THE PATIENT WAS DISCHARGED TO HOME. DUE TO THE DEVELOPMENT OF GRANULATION TISSUE AROUND THE STENT, INTERVENTIONS WERE PERFORMED 6, 10, 16 AND 19 MONTHS AFTER THE ORIGINAL DEPLOYMENT OF THE STENT. HOWEVER, GRANULATION TISSUE GRADUALLY GOT HARDER, AND THE TREATMENT WAS MORE DIFFICULT FOR THE PATIENT. IN ADDITION, STENT MIGRATION WAS ALSO SUSPECTED. SURGICAL STENT REMOVAL WAS THEN PLANNED AND WAS CONDUCTED WITH A RIGID ENDOSCOPE. THE (METAL) FRAMEWORK WITHIN THE STENT COULD BE GRASPED WITH ALLIGATOR FORCEPS. IT WAS TORN OFF INTO SMALL PIECES. AFTER REPEATING THE ATTEMPT FOR A FEW TIMES, THE CRANIAL END OF THE STENT WAS THEN GRASPED, AND THE STENT WAS SUCCESSFULLY EXPLANTED BY ROL
Patient problems: Granuloma
MAUDE report 15721806 ↗
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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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