System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA adverse event reports and recall history for system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment (product code PFV), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,684
- Deaths
- 31
- Injuries
- 798
- Malfunctions
- 1,855
Reports per year
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
- 2023-02-09Open, ClassifiedUnknown/Undetermined by firm
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Monitor system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment 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.