Devices

Boston Scientific Matrix2 360 UltraSoft SR Coils

  • Model / Serial
    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
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
  • 1 Event

Manufacturer

Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
  • Manufacturer Address
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA