Class 2 Device Recall Boston Scientific brand Matrix2 Firm 2D Coils.

• Date Initiated by Firm: October 19, 2010
• Date Posted: January 05, 2011
• Recall Status: Terminated on January 27, 2012
• Recall Number: Z-0858-2011
• Recall Event ID: 57179
• 510(K)Number: K031168 K012985
• Product Classification: vascular embolization device - Product Code HGC
• Product: Boston Scientific brand Matrix2 Firm 2D 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 M003480 1030 Matrix2¿ Firm 2D 10mm X 30cm 4801030 11253687,11766663 Oct2010 through 10mm X 30cm May2011 M0034801230 Matrix2¿ Firm 2D 12mm X 30cm 4801230 11766667,12707248 May2011 through 12mm X 30cm May2012 M0034801430 Matrix2¿ Firm 2D 14mm X 30cm 4801430 11697099 Apr2011 14mm X 30cm M0034801630 Matrix2¿ Firm 20 16mm X 30cm 480163 11426183,11766662 Dec2010 through 16mm X 30cm May2011 M0034801830 Matrix2¿ Firm 20 18mm X 30cm 4801830 11411206 Dec2010 18mm X 30cm M0034802030 Matrix2¿ Firm 20 20mm X 30cm 480203 11777398 May2011 20mm X 30cm M0034805150 Matrix2¿ Firm 20 5mm X 15cm 480515 11777399 May2011 5mm X 15cm M0034806150 Matrix2¿ Firm 20 6mm X 15cm 480615 11757096 Apr2011 6mm X 15cm M0034807200 Matrix2¿ Firm 20 7mm X 20cm 480720 11748387,12365836 Apr2011 through 7mm X20cm Jan2012 M0034808300 Matrix2¿ Firm 20 8mm X 30cm 480830 11297219,11991894,12365835 Oct2010 through 8mm X30cm Jan2012 M0034809300 Matrix2¿ Firm 20 9mm X 30cm 480930 11411626,11622081,12365834 Dec2010 through 9mm X30cm Jan2012
• 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: 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