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 dataset via the public data portal, enriched with detailed recall reason, consumer action, product name and manufacturer retrieved from the MFDS Medical Device Safety Information (emedi) detail pages and the public Product Information API. Recalls before 2017 may show only administrative fields, as detail pages are not available for older records.
• Australia — TGA. Database of Recalls, Advisories and Corrective actions (DRAC), filtered to neurovascular devices. Provides manufacturer, product, detailed reason, and hazard class (I/II/III). Refreshed periodically from the TGA export.
• Canada — Health Canada. Recalls and Safety Alerts open dataset (medical devices), filtered to neurointerventional products. Detailed issue and recommended action are retrieved from each recall's official Health Canada page. Provides product, issue, and recall class (Type I/II/III). Updated automatically (daily open-data feed).
• Japan — PMDA. Medical device recall records, filtered to neurovascular devices. Product, manufacturer, reason, and date are translated from Japanese. Refreshed periodically.
• Germany — BfArM. Field safety corrective actions (customer information) for medical devices, filtered to neurovascular products. Reasons are extracted from the official BfArM PDF and translated from German.
• United Kingdom — MHRA. Weekly Field Safety Notices (FSNs), filtered to neurovascular devices. Manufacturer, device, reason, and recommended action are extracted from each manufacturer's FSN PDF.
• Switzerland — Swissmedic. Field safety corrective actions (FSCA) and recalls from the public Swissmedic list, filtered to neurovascular devices. The detailed reason is extracted from the official manufacturer FSN PDF (English or German original) and translated. Updated automatically.
• France — ANSM. Safety information (product recalls, user information, quality defects) for medical devices from the ANSM public listing, filtered to neurovascular devices. The detailed reason is extracted from the official manufacturer FSN PDF (French or English original) and translated. Updated automatically.

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). For Korea, Australia, and Canada, where filtering is name-based, clearly non-neurovascular items are also excluded — such as fluoroscopy/X-ray imaging systems, aortic grafts, cardiopulmonary devices, electrodes, in-vitro diagnostics, and deep-brain-stimulation or open cranial-surgery tools — so that only neurointerventional devices remain.

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.

Source attribution & data use

NeuroAlert is a non-commercial, informational project. All underlying data belongs to the respective regulatory agencies and is reproduced here under their public-data terms, with attribution and links to the original records:

• Korea — MFDS Medical Device Safety Information (emedi). Detailed recall reason and consumer action are reproduced from the MFDS portal with the source clearly indicated and a link to the original page provided for every record. Reproduction is limited to factual recall information, used without distortion, in accordance with permission confirmed with the operating agency.
• Canada — Health Canada Recalls and Safety Alerts. Reproduced under the Open Government Licence – Canada: accuracy is preserved without altering the substance, the title and author (Health Canada) are indicated, and the original source URL is provided for each record.
• United States — FDA openFDA and Australia — TGA data are used from their respective open/public databases with attribution.
• Japan — PMDA, Germany — BfArM, United Kingdom — MHRA, Switzerland — Swissmedic, and France — ANSM data are reproduced from their public post-market safety publications with attribution and a link to each original notice.

Each record links back to its official source page. NeuroAlert does not modify the substance of any agency's information; summaries, when shown, preserve the original meaning. To report an inaccuracy, please use the contact page.