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Medtronic Surpass Evolve 4

No active recall

Manufacturer: Medtronic  · FDA product code: OUT  · Category: Intracranial Aneurysm Flow Diverter

Severity Snapshot

418 total reports2020-012026-03 date range90% physician / facility reported10% manufacturer reported37 SKU variants

Reporting Trend

Annual Reporting Volume

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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.

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