NeuroMAUDE
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Mitraclip

No active recall

FDA product code: DRA  · Category: Catheter, Steerable

Severity Snapshot

660 total reports2019-022026-03 date range99.4% physician / facility reported0.6% 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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