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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Boston Scientific brand Matrix2 Firm 2D 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-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/
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Robert Ware
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