NIVClass f
Coronary Covered Stent
FDA adverse event reports and recall history for coronary covered stent (product code NIV), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 693
- Deaths
- 96
- Injuries
- 179
- Malfunctions
- 418
Reports per year
114
115
3519
5420
7821
14922
14623
5724
8225
9026
Source: FDA adverse event reports by year received, 2014–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor coronary covered stent automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.