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U.S. Department of Health and Human Services

Class 2 Device Recall Neuroform 3 Microdelivery Stent System

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  Class 2 Device Recall Neuroform 3 Microdelivery Stent System see related information
Date Initiated by Firm March 01, 2010
Date Posted November 26, 2010
Recall Status1 Terminated 3 on November 26, 2010
Recall Number Z-0482-2011
Recall Event ID 55760
HDE Number H020002 
Product Classification Intracranial neurovascular stent - Product Code NJE
Product Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA
Code Information Model number: M003E3400300; expiration date October 2012   UPN Batch UPN Batch  M003E3300150 12907487 M003E3400150 12954887 M003E3300200 12915007 M003E3400200 12954888 M003E3350200 12915008 M003E3400300 12958309 M003E3450200 12915009 M003SNF330200 12965212 M003SNF330200 12915010 M003SNF335200 12965215 M003SNF340200 12915011 M003SNF335300 12968779 M003SNF345200 12915013 M003SNF335200 12969012 M003E3300300 12922996 M003SNF345300 12969013 M003E3350200 12923544 M003E3450150 12973549 M003E3300200 12925243 M003E3300200 12976185 M003E3400200 12925245 M003E3350300 12976374 M003E3400300 12925248 M003E3450200 12976378 M003E3450300 12925252 M003SNF330200 12978991 M003SNF325200 12929490 M003SNF335200 12969012 M003SNF30150 12929491 M003SNF340200 12979305 M003SNF335200 12929492 M003E3300200 12983886 M003SNF340200 12929494 M003SNF345300 12982462 M003SNF330150 12929491 M003E3400150 12990085 M003SNF345200 12929492 M003E3400200 12990088 M003SNF340200 12929494 M003E34000300 12990098 M003SNF340300 12929495 M003E3450200 12990124 M003SNF325200 12932459 M003SNF330200 12993187 M003SNF345200 12932945 M003SNF335150 12993189 M003SNF345300 12932946 M003SNF340200 12993190 M003E3350200 12936662 M003SNF340300 12993193 M003E3400200 12936665 M003E3350200 12996254 M003E3450150 12936668 M003SNF34150 12996255 M003E3450200 12940485 M003SNF335200 12996436 M003E3450300 12940950 M003E3400150 13010766 M003SNF335150 12943248 M003E3450300 13010770 M003SNF335200 12943594 M003SNF325200 13010771 M003SNF340200 12943598 M003SNF330150 13010772 M003E3250200 12947325 M003E3350200 13013322 M003E3300200 12947486 M003E3350300 13013323 M003E3450300 12947611 M003SNF335200 13017103 M003E3350200 12950991 M003SNF335200 12969012 M003SNF325150 12950988 M003SNF345300 12950989 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact
510-624-2544
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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 Zealand, Peru, Russian Federation, Sweden, Slovenia, Taiwan and Ukraine.
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.
HDE Database HDEs with Product Code = NJE and Original Applicant = Stryker Neurovascular
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