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Merit Medical Spectranetics Tightrail Rotating Dilator Sheath
No active recall
Manufacturer: Merit Medical · FDA product code: DRE · Category: Dilator, Vessel, For Percutaneous Catheterization
Severity Snapshot
169 total reports2014-08 – 2023-05 date range29.6% physician / facility reported70.4% 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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