Back to Merit Medical
Merit Medical Spectranetics
No active recall
Manufacturer: Merit Medical · FDA product code: DRE · Category: Dilator, Vessel, For Percutaneous Catheterization
Severity Snapshot
18 total reports2001-02 – 2020-12 date range12.5% physician / facility reported87.5% manufacturer reported7 SKU variants
Failure & Consequence Profiles
Top Failure Modes
Click any bar to view those reports ↓
Top Patient Outcomes
Click any bar to view those reports ↓
Reporting Trend
Annual Reporting Volume
Click any bar to view those reports ↓
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.
Filter by failure mode
Filter by outcome
Loading reports…