Class 2 Device Recall Boston Scientific Matrix2 360 UltraSoft SR Coils

• Date Initiated by Firm: October 19, 2010
• Date Posted: January 05, 2011
• Recall Status: Terminated on January 27, 2012
• Recall Number: Z-0863-2011
• Recall Event ID: 57179
• 510(K)Number: K012985 K031168
• Product Classification: vascular embolization device - Product Code HGC
• Product: Boston Scientific brand Matrix2 360 UltraSoft 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 11252230,11308509,11314276,11325957, 11336598, 11393159, 11395513, 11407112, 11451244,11531641,11550997,11560540, 11591562,11591706,11622023,11658783, 11658785,11658822,11676148,11676157, 11719463, 11730234, 11790200, 11800701, 11800705,11820288,11850793,11850843, 11873434,11908088,11934094,11958442, 11958449,11958467,11975078,11975174, 12018396,12061956,12082830,12093269, 12102499, 12102571, 12112302, 12119035, M003498204SRO Matrix2¿ 360 UltraSoft SR Coils 498204-SR 12130177,12156608,12156619,12172635, Oct2010 through 2mm x4cm 12175697,12176083,12176088,12176096, Aug2013 12176113,12176130,12214865,12229603, 12229665,12229709,12300883,12304385, 12316893,12330638,12372623,12383765, 12388036,12498742,12514610,12549119, 12549517,12579004,12669973,12670052, 12702899,12703158,12721628,12748406, 12775526,12792905,12810367,12847198, 12856251,12861682,12861685,12861728, 12902495,12909257,12920788,12922010, 12922031,12947555,13165095,13182078, 13740728 11285904, 11325811, 11330308, 11336721, 11344686,11429308,11430218,11491190, 11535756,11551320,11580678,11586999, 11606468,11640887,11676151,11676165, Matrix2¿ 360 UltraSoft SR Coils 11792442,11820281,11820295,11850792, Oct2010 through M003498206SRO 498206-SR 11850844,12043227,12119036,12130803, 2mm x6cm 12130817,12194743,12229581,12229605, Jun2013 12299406,12304391,12514596,12549520, 12650936,12792884,12861539,12861681, 12861726,12929268,12947551,12982270, 13165082,13165102,13600453 11290821,11306854,11414844,11415101, 11488903,11524527,11535144,11598085, 11658796,11730211,11756822,11800379, 11850788,11873437,11889319,11889933, 11958235,11958447,11975073,11975199, 11992222,12009642,12043109,12082849, 12102496,12112306,12130249,12156604, Matrix2¿ 360 UltraSoft SR Coils 12156607,12156621,12172961,12175696, Oct2010 through M003498304SRO 498304-SR 12175827,12176080,12176086,12176101, 3mm x4cm 12229674,12229678,12304388,12315366, Jan2013 12330621,12368749,12370624,12374136, 12374221,12376353,12379817,12383766, 12514603,12541587,12549512,12549525, 12579028,12636755,12703154,12703190, 12748467,12792896,12861696,12902497, 12922003,12922028,12947530,13165085, 13165101,13198188,13204883,13230537 I 11302950,11385614,11385615,11403344, 11440497,11444540,11475012,11523684, 11552540,11591597,11598082,11622020, 11640889, 11676150, 11730057, 11730213, 11788744, 11820175, 11820292, 11836537, 11850840,11873438,11908089,11925597, 11958473,11975164,11975183,11992201, 12009563,12009573,12009640,12026744, 12043228, 12067385, 12082843, 12082859, Matrix2¿ 360 UltraSoft SR Coils 12112303,12127498,12142026,12142038, Oct2010 through M003498306SRO 498306-SR 12176131,12188229,12194499,12194715, 3mm x6cm 12194731,12214717,12214815,12214857, Aug2013 12229662, 12299405, 12304191, 12304196, 12368752,12388034,12396262,12418213, 12424869,12427988,12439191,12439351, 12549523,12636732,12636756,12670041, 12702896,12703155,12703187,12753182, 12783356,12792890,12792921,12858819, 12861684, 12861720, 12922011, 12929262, 13109928, 13165083, 13165093, 13606646, 13740721 11321963,11325815,11341602,11440812, 11444365, 11488901, 11489569, 11550743, 11560542, 11598086, 11658799, 11730230, 11788749,11820283,11850855,11916970, M003498308SRO Matrix2¿ 360 UltraSoft SR Coils 498308-SR 11958232, 11958238, 11958448, 11958466, Nov2010 through 3mm x8cm 11996497,12102567,12130806,12194700, Jun2013 12194723,12214852,12229590,12549509, 12578759,12636733,12810343, 12885370, 12918062,12942555,12946179,13118674, 13165108,13182069,13600456 11293279,11318108,11345092,11407741, 11489572,11538865,11580677,11586997, 11658786,11712101,11719464,11789879, 11792443, 11820170, 11820282, 11850856, 11889925,11958236,11958456,12021661, Matrix2¿ 360 UltraSoft SR Coils 12026495,12026742,12082848,12112305, Oct2010 through M003498406SRO 498406-SR 12141859,12142033,12186120,12194702, 4mm x6cm 12194724, 12214850, 12229704, 12295452, Jun2013 12296704,12315362,12330599, 12439225, 12514516,12549514,12570929, 12669968, 12670046,12779824,12792888, 12805886, 12899134,12922013,12947538,13112464, 13165107,13610468 . 11314326,11320203,11336864,11396043, 11444147,11444545,11489567,11523682, 11538870, 11552547, 11560546, 11591708, 11658820,11676163,11676203,11788743, 11820174, 11820287, 11850846, 11873436, 11925602,11938492,11975160,11975176, 11975222,11992210,12009652,12061958, 12074313,12082844,12102564,12110478, Matrix2¿ 360 UltraSoft SR Coils 12119835, 12130819, 12194486, 12194491, Oct2010 through M003498408SRO 498408-SR 12194701,12194717,12194737,12214191, 4mm x8cm 12214718,12214817,12299414,12300716, Jun2013 12304387, 12330612, 12330647, 12385409, 12409147,12413139,12424873,12424877, 12439196, 12439352, 12567224, 12579029, 12669005, 12703185, 12721626, 12748407, 12783357,12791150,12922015,12929076, 12929261,12947543,12982329,12982336, 13116525,13164430,13165087,13182068, 13182074, 13602977 11321964, 11322842, 11432824, 11485038, 11531649, 11591564, 11591700, 11676177, 11697470,11712102,11719465,11721430, 11820323,11889309,11889316,11916971, 11952857,12026496,12043224,12061790, 12115320,12119907,12130813,12142087, M003498510SRO Matrix2¿ 360 UltraSoft SR Coils 498510-SR 12194718,12214197,12214714,12214842, Nov2010 through 5mmx10cm 12267364, 12304383, 12311944, 12315361, Jun2013 12315363,12356259,12392931,12404359, 12418210, 12439358, 12549513, 12634217, 12703183,12748428,12791153,12792898, 12861694,12922006, 12929075, 13164428, 13164795,13165092,13195731,13200123, 13233310,13603121 11323634,11325812,11329547,11403547, 11552535,11591701,11711974,11711979, Matrix2¿ 360 UltraSoft SR Coils 11766679, 11838297, 11850794, 11908093, Nov2010 through M003498515SRO 498515-SR 11946180,11991286,12214846,12226292, 5mmx15cm 12229666,12306631,12446872,12468830, Oct2012 12495253,12514592,12523445, 12579019, 12810368,12914092,12946427,13113054 11281623, 11380106, 11552542, 11658791, Matrix2¿ 360 UltraSoft SR Coils 11748395,11889312,12061947,12115321, Oct2010 through M003498610SRO 498610-SR 12142031,12299316,12370621,12446874, 6mmx10cm 12514609,12632702,13118675,13165080, Aug2013 13740727 11322855, 11385261, 11486201, 11531652, Matrix2¿ 360 UltraSoft SR Coils 11591702,11658823,11697473,11800199, Nov2010 through M003498615SRO 498615-SR 12194497, 12214193, 12226290, 12229705, 6mmx15cm 12439187,12491070,12495248,12514597, Aug2013 12947527,12965255,13740729
• 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