Recall Z-0482-2011 ยท NJE Intracranial Neurovascular Stent
Boston Scientific Corporation
Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA
| Date | Nov 26, 2010 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | The product may contain manufacturing aids (mandrels) which should not be present in the final product. If the mandrel remains in place, the catheter cannot be loaded over the required guidewire, so cannot be used. |
| Root cause | Process control |
| Action | Boston Scientific issued an Urgent Customer Notice dated March 1, 2010 to all US customers, with personal delivery by sales representative where applicable outside the US, identifying the affected device. Customers were instructed to return the device for replacement, and to return an acknowledgement form. Customers can contact Deborah Springer at Boston Scientific at 800-845-4598 about this recall. |
| Quantity | 638 units |
| Distribution | Worldwide Distribution: Throughout the US and to the countries of: Austria, Australia, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Germany, Denmark, Ecuador, Spain, France, Great Britain, Greece, Hungary, India, Ireland, Italy, South Korea, Luxemburg, Mexico, the Netherlands, New Zeal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.