Methodology

This page explains, in plain terms, how the data on NeuroAlert is gathered and why certain records are included or excluded. Transparency about method is essential because post-market surveillance data is easily misinterpreted.

Data sources

• United States — FDA openFDA. Device Recall and Device Adverse Event (MAUDE) endpoints, queried by FDA product code. Updated automatically.
• Korea — MFDS. Medical device recall and voluntary report datasets via the public data portal. Updated automatically.
• Japan — PMDA. JAMDER medical device malfunction case information, retrieved by Japanese generic device name. Reference data, updated periodically and not included in email alerts (PMDA has no public API, so automated real-time collection is avoided).

Device whitelist (inclusion)

Rather than keyword matching — which pulls in unrelated products — NeuroAlert filters by regulatory product classification. The U.S. whitelist includes the following FDA product codes:

• OUT — Intracranial aneurysm flow diverter
• HCG — Neurovascular embolization device (coils)
• KRD — Vascular device for promoting embolization
• NRY — Thrombus retriever catheter
• NIM — Carotid stent  ·  NJE — Intracranial neurovascular stent
• NTE — Carotid embolic capture  ·  QCA — Coil-assist stent
• MFE — Injectable embolic agent  ·  POL — Mechanical thrombectomy device
• DQY — Percutaneous catheter (limited to neurovascular brands only)

Exclusions

Codes that share keywords with neurovascular devices but are clinically unrelated are deliberately excluded — for example surgical staplers (GDW) and continuous-flush catheters (KRA). Japanese peripheral-vascular generic names and open-surgical aneurysm clips are likewise excluded.

Critical limitations

Reports may be duplicated across reporters, dates are sometimes missing or approximate, and a record's presence does not establish that a device caused harm. NeuroAlert presents records as-is from the source agencies and does not adjudicate causality.