| Class 2 Device Recall Boston Scientific brand Matrix2 Helical UltraSoft SR Coils | |
Date Initiated by Firm | October 19, 2010 |
Date Posted | January 05, 2011 |
Recall Status1 |
Terminated 3 on January 27, 2012 |
Recall Number | Z-0862-2011 |
Recall Event ID |
57179 |
510(K)Number | K012985 K031168 |
Product Classification |
vascular embolization device - Product Code HGC
|
Product | Boston Scientific brand Matrix2 Helical 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 11248651, 11291053, 11310207, 11323633, 11324250, 11385087, 11407756, 11410972, 11422254,11448538,11485969,11498926, 11505015,11531494,11550740,11552553, 11552580,11597969,11606471,11606472, 11676141,11676143,11676154,11676161, 11676175, 11730058, 11730228, 11730244, 11748054, 11800191, 11820286, 11838627, 11889317,11924292,11958237,11958446, 11958453,11958471,11975195,11988267, 12000346, 12008847, 12009650, 12018903, 12043119,12061957,12082823,12082831, 12082850,12102560,12102569,12112304, 12112308,12119827,12119836,12119901, 12130250, 12142092,12156613,12156623, 12161471,12176094,12176106,12176116, M003497202SRO Matrix2¿ Helical UltraSoft SR 497202-SR 12176127,12194710,12194727,12194750, Oct2010 through Coils 2mm x 2cm 12218091,12229544,12229549,12229554, Jun2013 12229582,12229588,12370629,12370632, 12378756,12379811,12379813,12413136, 12424868,12431048,12434612,12439198, 12439223,12468833,12495249,12514510, 12514517,12514583,12514600,12541586, 12549501,12549505,12549508,12549516, 12567226,12577905,12579009,12636525, 12636595,12636597,12636599,12636721, 12636734, 12659325, 12659332, 12703186, 12721622, 12721629, 12745887, 12748430, 12786766, 12792889,12792902,12810349, 12810366, 12841849, 12841850, 12841852, 12849196, 12861693, 12861725, 12891431, 12891438, 12914154, 12947533, 12947547, 12986455,13016337,13165099,13165118, 13194022, 13606643, 13606644 11285639, 11337201, 11373711, 11392488, 11395916,11445479,11472230,11494690, 11497220,11535565,11552559,11552581, 11639657,11676156,11788747,11850784, 11850797,11925583,11946186,11958478, 11975189,11996499,12008848,12018900, 12051398,12082825,12082840,12082861, 12112238,12119833,12127027,12149738, 12156620,12176104,12176119,12194716, M003497203SRO Matrix2¿ Helical UltraSoft SR 497203-SR 12194726,12194752,12229548,12229596, Oct2010 through Coils 2mm x 3cm 12306628,12320490,12359522,12361245, Jun2013 12396159,12409144,12418204,12424870, 12439224,12465526,12495252,12514506, 12514515,12514590,12521676,12567229, 12579025,12636729,12636751,12669006, 12674065,12703141,12703159,12703194, 12721499,12721630,12792887,12792906, 12792964,12861731,12895492,12903293, 12917355,12981468,13009557,13165104, 13204891,13608890 11287783,11300979,11319984,11432669, 11433113,11494689,11495753,11552552, 11597970,11634832,11676155,11712107, 11747856,11748041,11800376,11820294, 11850787,11850845,11925179,11925604, 11940589,11952667,11975171,12000343, 12018378,12018901,12047551,12069209, 12074315, 12119824, 12119831, 12119909, 12142085,12161472,12165272,12176115, Matrix2¿ Helical UltraSoft SR 12194705,12194732,12228152,12258932, Oct2010 through .J1003497204SRO 497204-SR 12299402,12330600,12359521,12392935, Coils 2mm x 4cm 12396260,12409145,12413137,12418203, Jun2013 12424876,12434613,12491075,12514508, 12514580,12514606,12521678,12578758, 12579000,12579006,12579014,12669975, 12702895,12703144,12703149,12721633, 12745888,12748426,12792907,12810358, 12841853,12841854,12841855,12841856, 12856504,12861689,12861730,12899758, 12917356,12922023,12968201,12981315, 12982266,13016333,13606211 11289497,11384552,11425586,11550741, 11597972, 11606469, 11676171, 11717889, 11820290,11838641,11925603,11940387, 11958450, 11975190, 11988269, 12007430, 12047552,12112300,12119900,12130811, 12155989,12156622,12176084,12176100, Matrix2¿ Helical UltraSoft SR 12176128,12194706,12194721,12228145, Oct2010 through M003497206SRO 497206-SR 12229670,12300719,12361244,12370633,
Coils 2mm x 6cm 12379814,12383762,12390150,12413134, Jun2013 12431051,12450911,12495254,12514519, 12514611,12559585,12636722,12636745, 12703146,12703192,12721631,12745886, 12783350,12792909,12845819,12861723, 12891437,12912266,12914288,12981912, 12982279,13194132,13608891 11287570,11345097,11415538,11502184, Matrix2¿ Helical UltraSoft SR 11538868, 11588278, 11641201, 11718833, Oct2010 through M003497208SRO 497208-SR 11838628,12007429,12229547,12299413, Coils 2mm x 8cm 12434615,12520964,12579022, 12695190, Jun2013 12792912,12947542,12982320,13610848 Matrix2¿ Helical UltraSoft SR 11249332,11337880,11501859,11606470, Oct2010 through M003497210SRO 497210-SR 11712100,11800700,12229558,12377448, Coils 2mm x 10cm 12469866,12514598,12982267,13204828 Dec2012 11378010,11502182,11622090,11697455, M003497215SRO Matrix2¿ Helical UltraSoft SR 497215-SR 11730220, 11786208, 12194494, 12214868, Dec2010 through Coils 2mm x 15cm 12374370,12439193,12495251,12514512, Dec2012 12634402,12792904,12982268,13194285 M003497253SRO Matrix2¿ Helical UltraSoft SR 497253-SR 11766416,12514587,12702892,12841857, May2011 through Coils 2.5mm x 3cm 13201016, 13221197 Dec2012 M003497254SRO Matrix2¿ Helical UltraSoft SR 497254-SR 11373706,11447829,11634829,11892358, Dec2010 through Coils 2.5mm x 4cm 12194722,12748425,13165111,13201017 Dec2012 M003497256SRO Matrix2¿ Helical UltraSoft SR 497256-SR 11766415,11782389,11788748,12214843, May2011 through Coils 2.5mm x 6cm 12377447,12383760,13201018,13233176 Jan2013 11378011,11560337,11634831,11748042, 11850799,11869795,11925581,11940585, 11952852,11975184,12026746,12061959, 12074301,12074302,12142034,12161321, 12165270,12194749,12229671,12241647, M003497304SRO Matrix2¿ Helical UltraSoft SR 497304-SR 12246983,12358559,12368753, 12383679, Dec2010 through Coils 3mm x 4cm 12388037, 12396261, 12418205, 12450912, Dec2012 12514509,12514605,12577902,12577910, 12634401,12659324,12692367,12702867, 12703156,12703199,12753183, 12786768, 12858818,12891629,12947531,12981683, 12999165,13204890 11286452,11327336,11408586,11444957, 11485583, 11531650, 11597971, 11800377, 11850785,11889927,11925598,11940588, 11958475,11996800,12004083,12026747, 12043117,12061981,12074038,12074039, 12112239,12142027,12156610,12176105, 12194484,12194488,12194496,12194714, Matrix2¿ Helical UltraSoft SR 12214713,12214811,12306635,12359020, Oct2010 through M003497306SRO 497306-SR 12365843,12378757,12385402,12390152, Coils 3mm x 6cm 12392936,12423456,12431049,12468832, Dec2012 12469526,12495245,12514513,12514593, 12549502,12549510,12549527,12636598, 12669972,12670047,12702626,12721496, 12721625,12721639,12753187,12786767, 12792901,12810351,12861737,12895628, 12909841,12929079,12947535,12968747, 13165105 11285911,11374154,11415732,11495563, M003497308SRO Matrix2¿ Helical UltraSoft SR 497308-SR 11526776, 11597973, 11838631, 11958464, Oct2010 through Coils 3mm x 8cm 12004084,12051399,12359021,12523447, Jun2013 12579021,12912187,13165094,13611268 11289762,11327222,11430208,11538867, M003497310SRO Matrix2¿ Helical UltraSoft SR 497310-SR 11580673,11711977,11748045,11792445, Oct2010 through Coils 3mm x 10cm 11820293,12102566,12142029,12359022, Dec2012 12523446,12947537,13204827,13204892 11374084,11425585,11495750,11531651, Matrix2¿ Helical UltraSoft SR 11552554,11622089,11712110,11795625, Dec2010 through M003497315SRO 497315-SR 11800194,11984851,12004085,12194751, Coils 3mm x 15cm 12514584,12559586,12636750,12779826, Dec2012 12903471, 13116656, 13165113 11377055,11426750,11477786,11505008, 11597975,11640819,11676158,11697457, 11697467,11718257,11719462,11748046, M003497320SRO Matrix2¿ Helical UltraSoft SR 497320-SR 11958460,11959904,12007428,12018397, Dec2010 through Coils 3mm x 20cm 12069208,12258931,12413138,12439181, Dec2012 12439194,12514507,12514595,12521677, 12636728,12753167,12792919,13165114, 13190676 11392486,11502702,11552558,11869786, 11934763,11952853,12009575,12021622, Matrix2¿ Helical UltraSoft SR 12043108,12069207,12074305,12093266, Dec2010 through M003497 406S RO 497406-SR 12110475, 12169001, 12214710, 12315368, Coils 4mm x 6cm 12372621,12385406,12514581,12549507, Nov2012 12670040,12702893,12703191,12810350, 12841858,12929267,12947521,13118720 1.1292934,11380184,11447831,11597968, 11800195,11843131,11924293,11934379, 11938495,11963591,11992217,12043114, 12069206,12074032,12074307,12093267, Matrix2¿ Helical UltraSoft SR 12161236,12176018,12176114,12306450, Oct2010 through M003497408SRO 497408-SR 12330566,12359024,12385401,12390153, Coils 4mm x 8cm 12392938,12431050,12514505,12514585, Dec2012 12521675,12636746,12669967,12670045, 12703143,12703196,12748434,12792254, 12792910,12841859,12899757,12947526, 12947554,13165109 11392633,11477710,11535147,11639656, M003497410SRO Matrix2¿ Helical UltraSoft SR 497410-SR 11766700,11850786,11934764,12102568, Dec2010 through Coils 4mm x 10cm 12165269,12374138,12514588,12912763, Aug2013 13165097,13204889,13569790,13740720 11374155,11403350,11444954,11484426, Matrix2¿ Helical UltraSoft SR 11542681,11597974,11697474,11792447, Dec2010 through M003497415SRO 497415-SR 11820179,12082862,12165271,12214844, Coils 4mm x 15cm 12229556,12377449,12383761,12579008, Aug2012 12792916,12896408,12947540 11391872,11472233,11538871,11586993, 11697472,11785998,11800709,11820177, M003497420SRO Matrix2¿ Helical UltraSoft SR 497420-SR 11850854,11934766,11958461,12000347, Dec2010 through Coils 4mm x 20cm 12012195,12069205,12439228,12514608, Dec2012 12549511,12783351,12810354,12971787, 13182061 M003497510SRO Matrix2¿ Helical UltraSoft SR 497510-SR 11448920,11580671,11785997,11820169, Dec2010 through Coils 5mm x 10cm 12229540,12439184,12965681 Aug2012 M003497515SRO Matrix2¿ Helical UltraSoft SR 497515-SR 11481347,11697449,11782386,11800703, Jan2011 through Coils 5mm x 15cm 12142081,12182653,12377451,12586142 Mar2012 11287209,11329750,11474491,11500844, M003497520SRO Matrix2¿ Helical UltraSoft SR 497520-SR 11634834,11838295,11850842,11958458, Oct2010 through Coils 5mm x 20cm 12194739,12258930,12439185,12465527, Sep2012 12849285,12906594,12982321,12989985 M003497610SRO Matrix2¿ Helical UltraSoft SR 497610-SR 11415310,11494692,11697447,11747879 Dec2010 through Coils 6mm x 10cm Apr2011 1003497615SRO Matrix2¿ Helical UltraSoft SR 497615-SR 11697445,11775114,12082856,12260480, Apr2011 through Coils 6mm x 15cm 12947552 Aug2012 Matrix2¿ Helical UltraSoft SR 11422255,11480517,11597977,11868815, Dec2010 through M003497620SRO 497620-SR 12119834,12142025,12182652,12494077, Coils 6mm x 20cm 12791146,12792893,12982269,13165112 Dec2012 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HGC
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