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U.S. Department of Health and Human Services

Class 2 Device Recall NexStent Monorail Carotid Stent System

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  Class 2 Device Recall NexStent Monorail Carotid Stent System see related information
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
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
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.
PMA Database PMAs with Product Code = NIM and Original Applicant = BOSTON SCIENTIFIC
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