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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific brand Matrix 2Helical Soft SR Coils.

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  Class 2 Device Recall Boston Scientific brand Matrix 2Helical Soft SR Coils. see related information
Date Initiated by Firm October 19, 2010
Date Posted January 05, 2011
Recall Status1 Terminated 3 on January 27, 2012
Recall Number Z-0855-2011
Recall Event ID 57179
510(K)Number K031168  K012985  
Product Classification vascular embolization device - Product Code HGC
Product Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
Code Information Material Product Description Catalog # Batch Numbers Expiry Date  M003471204SRO Matrix2¿ Helical Soft SR Coils 471204-SR 11297523,12469527 Oct2010 through   2mm x4cm Feb2012  M003471206SRO Matrix2¿ Helical Soft SR Coils 471206-SR 11422256,11697451,11952856,12361059 Dec2010 through   2mm x6cm Dec2011  M003471208SRO Matrix2¿ Helical Soft SR Coils 471208-SR 11389025,11552556,12514612,13606645 Dec2010 through   2mm x8cm Jun2013  
Recalling Firm/
Manufacturer		 Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Robert Ware
510-624-2544
Manufacturer Reason
for Recall		 The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
FDA Determined
Cause 2		 Process control
Action US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
Quantity in Commerce 77,364 total units
Distribution Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.
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.
510(K) Database 510(K)s with Product Code = HGC and Original Applicant = BOSTON SCIENTIFIC, TARGET
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