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Merit Medical Lead Extraction Evolution Mechanical Dilator Sheath Set
No active recall
Manufacturer: Merit Medical · FDA product code: DRE · Category: Dilator, Vessel, For Percutaneous Catheterization
Severity Snapshot
44 total reports2008-10 – 2019-12 date range0% physician / facility reported100% manufacturer reported2 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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