Boston Scientific Corporation One Boston Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100
Brand
Boston Scientific Corporation One Boston
Lot Codes / Batch Numbers
Lot Numbers: 8243354, 8243355, 8243356, 8521620, 8913445
Products Sold
Lot Numbers: 8243354, 8243355, 8243356, 8521620, 8913445
Boston Scientific Corporation One Boston is recalling Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100 due to Guidewire restriction during use (excessive adhesive in the guidewire lumen). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Guidewire restriction during use (excessive adhesive in the guidewire lumen)
Recommended Action
Per FDA guidance
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.
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