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Medtronic Pipeline Flex Embolization
No active recall
Manufacturer: Medtronic · FDA product code: OUT · Category: Intracranial Aneurysm Flow Diverter
Severity Snapshot
827 total reports2015-03 – 2026-03 date range7.9% physician / facility reported92.1% manufacturer reported3 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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