| Class 2 Device Recall NexStent Monorail Carotid Stent System | |
Date Initiated by Firm | May 15, 2006 |
Date Posted | September 16, 2008 |
Recall Status1 |
Terminated 3 on September 25, 2008 |
Recall Number | Z-2089-2008 |
Recall Event ID |
48430 |
PMA Number | P050025 |
Product Classification |
Carotid Stent - Product Code NIM
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Product | 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. |
Code Information |
All products distributed between 04/07/2005 through 04/28/2006, Lot numbers (batch numbers are the same as lot numbers, without preceeding letter): c45301, c50101, c50202, c50203, c50204, c50205, c50301, c50302, c50303, c50304, c50305, c50401, c50402, c50403, c50404, c50405, c50406, c50501, c50502, c50503, c50601, c50602, c50701, c50702, c50703, c50704, c50801, c50802, c50803, c50804, c50805, c50901, c50902, c50903, c50904, c51001, c51002, c51003, c51101, c51102, c51201, c51202, c51301, c51302, c51303, c51304, c51305, c51401, c51402, c51403, c51404, c51405, c51601, c51602, c51701, c51702, c51801, c51802, c51803, c51804, c52101, c52201, c52202, c52203, c52401, c52402, c52403, c52501, c52502, c52503, c52504, c52505, c52601, c52602, c52603, c52701, c52702, c52703, c52704, c52801, c52802, c52901, c52902, c52903, c52904, c53001, c53003, c53103, and c53801 |
Recalling Firm/ Manufacturer |
Boston Scientific Cupertino, Corporation 10231 Bubb Rd Cupertino CA 95014-4167
|
For Additional Information Contact | 408-517-2800 |
Manufacturer Reason for Recall | Tip may detach from stent delivery system. |
FDA Determined Cause 2 | 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 in Commerce | 1326 units |
Distribution | 188 consignees throughout Europe received the product. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = NIM
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