Device Recall ev3 Primus GPS Biliary Stent and Delivery System

Model number BXB35-05-17-120 Lot 1049856 Model number BXB35-06-17-120 Lot 1049864

Gastroenterology-Urology Devices

2

Yes

Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV

ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.