Recall Z-2089-2008 ยท NIM Stent, Carotid
Boston Scientific Cupertino, Corporation
NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp, Natick, MA.
| Date | Sep 16, 2008 (initiated May 15, 2006) |
| Status | Terminated |
| Reason | Tip may detach from stent delivery system. |
| Root cause | Process control |
| Action | The firm issued notification letters and information sheets to consignees describing the risks. The firm requested the products be returned to the firm. If you have questions, contact the firm at 408-517-2800. |
| Quantity | 1326 units |
| Distribution | 188 consignees throughout Europe received the product. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.