Recall Z-2052-2009 ยท NJE Intracranial Neurovascular Stent
Boston Scientific Corporation
Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
| Date | Sep 9, 2009 (initiated May 8, 2009) |
| Status | Terminated |
| Reason | Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton. |
| Root cause | Employee error |
| Action | The firm issued an Urgent Product Field Action Notice to all listed customers, along with a reply verification form, requesting the return of affected products. |
| Quantity | 8 units |
| Distribution | International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.