| Class 2 Device Recall Boston Scientific brand Matrix 3D Omega Standard Coils | |
Date Initiated by Firm | October 19, 2010 |
Date Posted | January 05, 2011 |
Recall Status1 |
Terminated 3 on January 27, 2012 |
Recall Number | Z-0857-2011 |
Recall Event ID |
57179 |
510(K)Number | K012985 K031168 |
Product Classification |
Clamp, Uterine - Product Code HGC
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Product | Boston Scientific brand Matrix 3D Omega Standard 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 M0034751030 Matrix2¿ 3D-Omega Standard 475103 13097570 Oct2012 Coils 1 Omm x 30cm M0034753060 Matrix2¿ 3D-Omega Standard 475306 13204826 Dec2012 Coils 3mm x 6cm M0034754060 Matrix2¿ 3D-Omega Standard 475406 13199749 Dec2012 Coils 4mm x 6cm M0034755080 Matrix2¿ 3D-Omega Standard 475508 13204829 Dec2012 Coils 5mm x 8cm M0034755100 Matrix2¿ 3D-Omega Standard 475510 13097571 Oct2012 Coils 5mm x 10cm |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515
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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 |
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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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510(K) Database | 510(K)s with Product Code = HGC
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