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Penumbra System Ace 68 Hi-Flow
No active recall
Manufacturer: Penumbra · FDA product code: NRY · Category: Catheter, Thrombus Retriever
Severity Snapshot
107 total reports2016-08 – 2019-03 date range0% physician / facility reported100% manufacturer reported2 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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