Recall Z-1161-2007 ยท NIM Stent, Carotid
Boston Scientific Corporation
Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA
| Date | Aug 9, 2007 (initiated May 1, 2007) |
| Status | Terminated |
| Reason | Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent. |
| Root cause | Other |
| Action | On May 1, 2007, Boston Scientific initiated a Customer Notification worldwide. On May 21, 2007 Boston Scientific expanded this field action to a recall/removal status for Germany. Affected customers were notified in Germany on May 24, 2007. |
| Quantity | 2487 |
| Distribution | Worldwide, including USA, France, Italy, Germany, Belgium, Cyprus, Austria, Spain, Finland, Netherlands, Luxembourg, Romania , Czech Republic, Poland, Israel, Hungary, New Zealand, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.