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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Boston Scientific brand Matrix 2D 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-0856-2011
Recall Event ID 57179
510(K)Number K031168  K012985  
Product Classification vascular embolization device - Product Code HGC
Product Boston Scientific brand Matrix 2D 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   M003471304SRO Matrix2¿ 2D Soft SR Coils 3mm 471304-SR 11391991,11697446,11721433,11775115, Dec2010 through   x4cm 12579020 Mar2012  M003471306SRO Matrix2¿ 2D Soft SR Coils 3mm 471306-SR 11498868,11775116,12194493,12385403, Jan2011 through   x6cm 12520966, 12861735 Jul2012  M003471308SRO Matrix2¿ 2D Soft SR Coils 3mm 471308-SR 11481348,11792449,11820171,12401292, Jan2011 through   x8cm 12514514, 12792920 Jun2012  M003471310SRO Matrix2¿ 2D Soft SR Coils 3mm 471310-SR 11342011,11634830,12390151,12439220, Nov2010 through   x 10cm 12982264 Sep2012  M003471406SRO Matrix2¿ 2D Soft SR Coils 4mm 471406-SR 11502704,11641203,12081496,12474445, Jan2011 through   x6cm 12795286 Jun2012   11622088,11718835,11869785,11925599,   11940238,11985921,11992220,12156354,  M003471408SRO Matrix2¿ 2D Soft SR Coils 4mm 471408-SR 12156603,12176007,12176017,12194725, Mar2011 through   x8cm 12295449,12356324,12356325,12514591, Dec2012   12636738,12748405,12748465,12845925,   12891630,12906595,13200124   Matrix2¿ 2D Soft SR Coils 4mm 11310206,11552557,11766672,12119904, Oct2010 through  M003471410SRO 471410-SR 12161473,12409142,12439231,12791147,   x 10cm 12792538 Jun2012  M003471508SRO Matrix2¿ 2D Soft SR Coils 5mm 471508-SR 11622083,12176098,12229542,12721621, Mar2011 through   x8cm 13020445 Sep2012   11800192,11869788,11925606,11940381,   11963592,11996801,12155987,12156601,  M003471510SRO Matrix2¿ 2D Soft SR Coils 5mm 471510-SR 12176008,12194708,12314468,12330568, May2011 through   x 10cm 12368755,12409141,12514589,12636752, Jun2013   12669963,12670049,12703140,12753166,   12792908,12861687,12981682,13603463  M003471515SRO Matrix2¿ 2D Soft SR Coils 5mm 471515-SR 11384554,11641206,12176118,12182654, Dec2010 through   x 15cm 12246986,12649894,13020067 Sep2012   11384857,11748388,11925177,11940389,  M003471610SRO Matrix2¿ 2D Soft SR Coils 6mm 471610-SR 11967352,12112307,12155988,12176015, Dec2010 through   x 10cm 12330561,12356327,12374220,12847321, Aug2012   12947525,12971457  M003471615SRO Matrix2¿ 2D Soft SR Coils 6mm 471615-SR 11532410,11800196 Feb2011 through   x 15cm May2011  1003471620SRO Matrix2¿ 2D Soft SR Coils 6mm 471620-SR 11373732,11634833,12261958,12649895, Dec2010 through   x20cm 12792911 Jun2012  M003471710SRO Matrix2¿ 2D Soft SR Coils 7mm 471710-SR 12499178,13108359 Feb2012 through   x 10cm Oct2012  M003471715SRO Matrix2¿ 2D Soft SR Coils 7mm 471715-SR 11820280,12229546,12249163 May2011 through   x 15cm Nov2011  M003471720SRO Matrix2¿ 2D Soft SR Coils 7mm 471720-SR 11622084,11938494,12246985,12579366 Mar2011 through   x20cm Mar2012  M003471820SRO Matrix2¿ 2D Soft SR Coils 8mm 471820-SR 11622082,11766666 Mar2011 through   x20cm May2011  M003471830SRO Matrix2¿ 2D Soft SR Coils 8mm 471830-SR 11697466,12229584 Apr2011 through   x30cm Nov2011  
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