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Penumbra Solitaire FR3
No active recall
Manufacturer: Penumbra · FDA product code: NRY · Category: Catheter, Thrombus Retriever
Severity Snapshot
129 total reports2017-05 – 2025-07 date range65.1% physician / facility reported34.9% 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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