Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
Lot Codes / Batch Numbers
Lot no. 923291, 923290
Products Sold
Lot no. 923291, 923290
A medical device manufacturer is recalling Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. due to A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.
Recommended Action
Per FDA guidance
Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.
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
AL, AZ, FL, KS, LA, MS, NE, NY, NC, TX
Page updated: Jan 10, 2026