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Medtronic Pipeline Flex W Shield Technology
No active recall
Manufacturer: Medtronic · FDA product code: OUT · Category: Intracranial Aneurysm Flow Diverter
Severity Snapshot
2,870 total reports2016-05 – 2026-03 date range77.9% physician / facility reported22.1% manufacturer reported1 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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