NeuroMAUDE
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Axium Prime Brpl Hlx

No active recall

FDA product code: KRD  · Category: Device, Vascular, For Promoting Embolization

Severity Snapshot

574 total reports2015-122026-03 date range62.7% physician / facility reported37.3% 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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