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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
Model number BXB35-05-17-120 Lot 1049856 Model number BXB35-06-17-120 Lot 1049864
Products Sold
Model number BXB35-05-17-120 Lot 1049856 Model number BXB35-06-17-120 Lot 1049864
A medical device manufacturer is recalling ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is ma due to A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
Recommended Action
Per FDA guidance
ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, MD, MA, MS, NY, PA, TN, TX, WA, WV
Page updated: Jan 10, 2026