Recall Z-1548-2008 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc
ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,
| Date | Sep 26, 2008 (initiated Jul 1, 2008) |
| Status | Terminated |
| Reason | ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended. |
| Root cause | Employee error |
| Action | Consignees were sent a "Medical Device Recall" letter dated 7/1/08. The letter described the product, problem and action to be taken. The letter also requested to complete and return The Field Action Reconciliation Form. For further information, please contact Customer Service at 800-716-6700. |
| Quantity | 212 |
| Distribution | Worldwide Distribution including states of AL,AZ, CA, CO, CT, FL, IL, IN, IA, KS, KY, LA,ME, MA, MI, MN, MO, MT, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, WV, WI, and VA. Counties of SWEDEN, TUNISIA, SWITZERLAND, GERMANY, ITALY, SLOVENIA, FRANCE, BELGIUM, UNITED KINGDOM, TURKEY, FINLAND, LITHUANIA, a |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061566 | PRIMUS GPS BILIARY STENT SYSTEM Ev3, Inc., Aug 31, 2006 |