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Penumbra Impact
No active recall
Manufacturer: Penumbra · FDA product code: BTA · Category: Pump, Portable, Aspiration (Manual Or Powered)
Severity Snapshot
62 total reports2005-11 – 2012-02 date range0% physician / facility reported100% 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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