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Merit Medical Merit Mak
No active recall
Manufacturer: Merit Medical · FDA product code: DRE · Category: Dilator, Vessel, For Percutaneous Catheterization
Severity Snapshot
39 total reports2004-04 – 2025-03 date range10.3% physician / facility reported89.7% manufacturer reported5 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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