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Merit Medical Super Sheath Introducer Sheath
No active recall
Manufacturer: Merit Medical · FDA product code: DRE · Category: Dilator, Vessel, For Percutaneous Catheterization
Severity Snapshot
35 total reports2006-04 – 2024-05 date range2.9% physician / facility reported97.1% 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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