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U.S. Department of Health and Human Services

Class 2 Device Recall Nexstent Carotid Stent and Monorail Delivery System

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  Class 2 Device Recall Nexstent Carotid Stent and Monorail Delivery System see related information
Date Initiated by Firm May 01, 2007
Date Posted August 09, 2007
Recall Status1 Terminated 3 on March 02, 2008
Recall Number Z-1161-2007
Recall Event ID 38117
PMA Number P050025 
Product Classification carotid artery stent - Product Code NIM
Product Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA
Code Information Lots distributed in US: C64701, C64702, C64703, C64704, C64705, C64706, C64801, C64802, C64803, C64804, C70101, C70102, C70103, C70104, C70105, C70201, C70202, C70203, C70204, C70205, C70206, C70207, C70208, C70209, C70210, C70211, C70212, C70213, C70214, C70215, C70216, C70217, C70218, C70219, C70220, C70221, C70222, C70223, C70224, C70225, C70226, C70227, C70228, C70229, C70230, C70231, C70232, C70233, C70301. Lots distributed OUS: C51301, C52501, C52502, C52703, C61401, C61402, C61403, C61501, C61502, C61503, C61601, C61602, C61603, C61604, C61605, C61701, C61702, C61801, C61802, C61803, C61804, C61805, C61901, C61902,  C62001, C62002, C62003, C62004, C63701, C63901, C64001, C64002, C64101, C64102, C64501, C65101, C65102.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760
For Additional Information Contact
763-494-1634
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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.
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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