Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100

On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.