Recall Z-0604-2007 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100
| Date | Mar 13, 2007 (initiated Dec 20, 2006) |
| Status | Terminated |
| Reason | Guidewire restriction during use (excessive adhesive in the guidewire lumen) |
| Root cause | Other |
| Action | 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. |
| Quantity | 8,511 for Recalls Z-0604-0609-2007 |
| Distribution | Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964119 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS Boston Scientific Scimed, Inc., Apr 28, 1997 |