AERO® 00884450030691Recalls & 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 00884450030691), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Rupture1
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.
InjuryJan 13, 2021Fracture; Material Rupture; Fracture; Material Rupture
THE ACCOUNT ALLEGES THAT POST TRACHEOBRONCHIAL STENT PLACEMENT, THE TRACHEOBRONCHIAL STENT HAD FRACTURED IN VI-VO. THE PATIENT RETURNED TO THE HEALTHCARE FACILITY TO UNDERGO A STENT REMOVAL PROCEDURE. THE FRACTURED STENT WAS SUCCESSFULLY REMOVED BY THE PHYSICIAN AND A NEW TRACHEOBRONCHIAL STENT WAS DEPLOYED WITHOUT ANY ADDITIONAL CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11158930 ↗
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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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