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Penumbra Axium Platinum Helical Detachable Coil
No active recall
Manufacturer: Penumbra · FDA product code: HCG · Category: Device, Neurovascular Embolization
Severity Snapshot
59 total reports2013-08 – 2014-09 date range6.8% physician / facility reported93.2% manufacturer reported1 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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