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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Matrix2 360 UltraSoft SR Coils

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  Class 2 Device Recall Boston Scientific Matrix2 360 UltraSoft 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-0863-2011
Recall Event ID 57179
510(K)Number K031168  K012985  
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 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
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