Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use before 2009-02 Sterile EO Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 Intended as a palliative treatment of malignant neoplasms in the biliary tree. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use before 2009-02 Sterile EO Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 Intended as a palliative treatment of malignant neoplasms in the biliary tree.
Lot Codes / Batch Numbers
Lot 2092998
Products Sold
Lot 2092998
A medical device manufacturer is recalling Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use before 200 due to A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm ste. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent.
Recommended Action
Per FDA guidance
The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.
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 noticePage updated: Jan 10, 2026