Back to Neurovascular
Enterprise Vascular Reconstruction Device And
No active recall
FDA product code: NJE · Category: Intracranial Neurovascular Stent
Severity Snapshot
1,511 total reports2007-06 – 2018-04 date range0.3% physician / facility reported99.7% manufacturer reported1 SKU variants
Reporting Trend
Annual Reporting Volume
Click any bar to view those reports ↓
Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.
Reported Events
Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.
Loading reports…