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Hydromark Breast Biopsy Site Marker
No active recall
FDA product code: NEU · Category: Marker, Radiographic, Implantable
Severity Snapshot
39 total reports2017-04 – 2023-11 date range28.9% physician / facility reported71.1% 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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