Class 2 Device Recall Boston Scientific brand Matrix2 360 Soft SR Coils.

• Date Initiated by Firm: October 19, 2010
• Date Posted: January 05, 2011
• Recall Status: Terminated on January 27, 2012
• Recall Number: Z-0859-2011
• Recall Event ID: 57179
• 510(K)Number: K012985 K031168
• Product Classification: vascular embolization device - Product Code HGC
• Product: Boston Scientific brand Matrix2 360 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 11327721,11504445,11552548,11598084, Matrix2 360 Soft SR Coils 3mm 11658821,11992209,12061946,12074034, Nov2010 through M003490304SRO 490304-SR 12142090,12194733,12229550,12260121, x4cm 12439221,12514518,12570927,12579017, Aug2012 12792914, 12899133 11249858,11314331,11340645,11474490, 11552544,11598080,11658789,11712104, 11730236,11748424,11829804,11850851, 11889315,11924291,11958451,11991899, 11992200,12009564,12061951,12067387, 12074300,12119830,12119908,12142037, Matrix2 360 Soft SR Coils 3mm 12186121,12194487,12194492,12194709, Oct2010 through ,1003490306SRO 490306-SR 12194729,12214847,12229676,12291688, x6cm 12311954,12315364,12317008,12404354, Dec2012 12431055,12439440,12465571,12514602, 12636739,12670100,12698231,12721495, 12748470,12792883,12810371,12856503, 12861688,12874522,12922027,12929077, 12982322,13164432,13164796,13165110, 13204836 11391994,11451245,11497223,11560544, 11622024,11697452,11697465,11730229, 11790203,11820285,11889311,12009567, 12009651,12043116,12061789,12067386, 12074308,12119826,12119905,12141858, 12142023,12142080,12194713,12194748, M003490308SRO Matrix2 360 Soft SR Coils 3mm 490308-SR 12229543,12229557,12291689,12311955, Dec2010 through x8cm 12388033,12401320,12418209,12514601, Aug2013 12549500,12549515,12579001,12579011, 12636731,12669965,12669977,12695189, 12698227,12748429,12783352,12792903, 12861733,12878386,12922007,12947549, 12982323,12982331,13108353,13165103, 13611875,13740715 11248431,11435810,11488182,11538866, 11560545,11580674,11586995,11790201, 11820178,11850847,11873431,11925605, 11940385, 11975165, 11975196, 11992221, 12043112,12102495,12102570,12130816, Matrix2 360 Soft SR Coils 4mm 12141856,12142021,12156618,12176087, Oct2010 through M003490406SRO 490406-SR 12176123,12214854,12267374,12320493, x6cm 12324045,12330630,12358025,12376354, Dec2012 12401323, 12404357, 12427985, 12434604, 12446873,12579365,12589398,12636758, 12669962,12669976,12703153,12810347, 12861698,12903423,12922029,12947553, 13016331, 13165116 11293329,11378006,11388501,11399189, 11435809,11440484,11486119,11535146, 11552543,11560543,11597979,11622027, 11658787,11676144,11676159,11718824, 11873435,11889920,11908086,11958455, 11975069,11975169,11992215,12009576, 12009646,12026499,12043220,12061955, 12082847,12119839,12130814,12142089, 12156612,12156625,12175821,12176089, 12176103,12176120,12214807,12214856, Matrix2 360 Soft SR Coils 4mm 12225445,12226291,12228156,12260124, Oct2010 through M003490408SRO 490408-SR 12330661,12370631,12372625,12374139, x8cm 12377446,12388031,12439195,12439232, Jun2013 12465567, 12474440, 12474444, 12495244, 12514511,12514582,12514604,12553672, 12567223, 12570928, 12582206, 12636730, 12636747, 12670043, 12688725, 12703180, 12753145,12753168,12792891,12792918, 12856252,12861683,12861699,12882522, 12909275,12922001,12947529,12947548, 12981235,12982325,12982333,13113667, 13164429,13165088,13165106,13204887, 13614550 11241568,11295953,11318655,11388824, 11418198,11418199,11516242,11552539, 11598087,11676147,11756825,11838296, 11838633,11869781,11889923,11925601, 11940383,11963587,11975076,11975177, 11992204, 11992211, 12009654, 12047550, 12102498,12102572,12112301,12127497, 12142022,12142032,12161233,12194719, M003490510SRO Matrix2 360 Soft SR Coils 5mm 490510-SR 12194746,12210213,12228826,12229587, Oct2010 through x 10cm 12330645, 12368750, 12370623, 12379815, Aug2013 12427984, 12434603, 12465569, 12495250, 12549419,12549506,12549519,12577901, 12579023,12669966,12669974,12698233, 12703157,12703197,12792900,12810352, 12859278, 12861729, 12902494, 12914299, 12921998, 12947534, 12982326, 12982334, 13016338,13026037,13115713,13165098, 13182062,13190678,13740723 11241926,11323157,11388508,11411633, 11472604,11497222,11497859,11552549, 11606463,11640894,11676145,11721432, 11756827,11820291,11850795,11869792, 11889924,11938493,11940586,11963588, 11967351,11975074,11975172,12000344, 12018387,12047344,12102497,12110476, 12112237,12127025,12142024,12142083, 12161228,12194730,12214802,12214859, M003490515SRO Matrix2 360 Soft SR Coils 5mm 490515-SR 12229580,12260120,12300881,12306629, Oct2010 through x 15cm 12315370,12325704,12330628,12358024, Dec2012 12388029,12392932,12404351,12404358, 12409148,12413361,12424871,12434608, 12439355,12579003,12632701,12669001, 12670051,12698225,12703147,12703181, 12721620,12721636,12792915,12810345, 12810362,12856010,12861695,12888522, 12909744,12920953, 12921984, 12922004, 12929263,12982271,13165090,13165119, 13182076 11299320,11329549,11340642,11489571, 11552541,11712108,11721431,11748391, 11869789,11908094,11963589,11967349, 11975170,12061949,12074316,12141375, 12156611,12169000,12176013,12176090, M003490610SRO Matrix2 360 Soft SR Coils 6mm 490610-SR 12214809,12259818,12291684,12295456, Oct2010 through x 10cm 12311956,12330632,12378758,12392930, Jan2013 12401019,12404355,12404521,12424874, 12431054,12431056,12434610,12579027, 12669978,12792895,12918642,12947544, 12982272,12990294,13016325,13113185, 13164431,13182075,13233311 11319664,11344931,11404790,11491182, 11535755, 11552536, 11591703, 11606465, 11658794,11676146,11766676,11800186, 11838299,11850782,11850790,11850850, 11889929,11924290,11934376,11975181, 11992205,12009572,12009647,12061952, 12067384,12074309,12074310,12119828, 12119837,12130808,12142039,12187530, M003490615SRO Matrix2 360 Soft SR Coils 6mm 490615-SR 12194495,12194712,12194740,12214819, Nov2010 through x 15cm 12299317,12299410,12306630,12315369, Sep2012 12356256,12358026,12401293,12404352, 12404356, 12413360, 12413362, 12424875, 12434602,12439442,12577739,12579015, 12632700,12669000,12670054,12703188, 12721627,12748472,12810341,12810348, 12838009, 12849284, 12860900, 12861724, 12903859,12906596,12921997,12922014, 12981467, 13015393, 13016327 Matrix2 360 Soft SR Coils 7mm 11396531,11552538,11766668,11992206, Dec2010 through M003490710SRO 490710-SR 12074303, 12259819, 12370622, 12431053, x 10cm 12964403 Aug2012 11247286,11330876,11399084,11520021, 11591598,11697443,11697461,11730232, 11756828,11916973,11991893,12026494, 12047549,12051396,12119832,12168018, 12188228,12194707,12194754,12214195, M003490715SRO Matrix2 360 Soft SR Coils 7mm 490715-SR 12225279,12291685,12296703,12315365, Oct2010 through x 15cm 12330625,12356320,12365840,12392933, Aug2013 12404522,12409149,12434607,12439356, 12549524,12579012,12636741,12670048, 12783355,12810342,12912905,12922030, 12982327,12982335,13182064,13202907, 13740724 11377048,11388828,11433319,11475013, 11491419,11497447,11560339,11697464, 11730226, 11748420, 11756830, 11829805, M003490720SRO Matrix2 360 Soft SR Coils 7mm 490720-SR 11838635, 11908085, 11985698, 12102494, Dec2010 through x20cm 12102565,12127495,12161470,12214855, Dec2012 12228403,12519871,12549526,12703220, 12791151,12792885,12917401,12982273, 13164433,13174305 11249122,11307527,11396327,11521506, 11552545,11622021,11712106,11748392, 11756831,11850798,11869806,11940395, 11963590,11975175,12018395,12061950, 12082824,12102573,12130175,12155990, M003490820SRO Matrix2 360 Soft SR Coils 8mm 490820-SR 12176091,12176132,12214706,12214712, Oct2010 through x20cm 12214848,12295450,12295454,12296712, Dec2012 12296713,12304194,12304198,12330636, 12358027,12364673,12474441,12514599, 12577900, 12636735, 12792882, 12922025, 12982274,13016323,13115792,13164434, 13182066 11342412,11475011,11504449,11543008, 11560541, 11658790, 11676153, 11790202, M003490830SRO Matrix2 360 Soft SR Coils 8mm 490830-SR 11850783, 11850796,11946181,12047553, Nov2010 through x30cm 12119902,12214863,12225442,12229613, Dec2012 12567225, 12636736,12906335,12947546, 13019231,13164435,13181899,13190677
• 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