Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100
FDA Recall Z-0604-2007 · Posted 2007-03-13
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2006-12-20
Date Terminated2007-12-12
Product Quantity8,511 for Recalls Z-0604-0609-2007
Reason for Recall
Guidewire restriction during use (excessive adhesive in the guidewire lumen)
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.