Boston Scientific Corporation
Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
| Date | Jul 15, 2003 (initiated Jun 26, 2003) |
| Status | Terminated |
| Reason | Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm |
| Root cause | Other |
| Action | Boston Scientific notified domestic and internationnal accounts by letter on 6/26/03. Users are advised to check inventory and return product. A Reply Verification form was required to returned by fax to determine accountability. |
| Quantity | 23 units |
| Distribution | CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991056 | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM Boston Scientific Corp, Jun 22, 1999 |