NeuroMAUDE
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Penumbra Target XL 360 Standard

No active recall

Manufacturer: Penumbra  · FDA product code: HCG  · Category: Device, Neurovascular Embolization

Severity Snapshot

103 total reports2013-112025-10 date range25.2% physician / facility reported74.8% manufacturer reported12 SKU variants

Failure & Consequence Profiles

Top Failure Modes

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Top Patient Outcomes

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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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