Events

Recall of Boston Scientific brand Matrix2 Helical UltraSoft SR Coils

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57179
  • Event Risk Class
    Class 2
  • Event Number
    Z-0862-2011
  • Event Initiated Date
    2010-10-19
  • Event Date Posted
    2011-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96014
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    vascular embolization device - Product Code HGC
  • Reason
    The product appears to have premature degradation of the pgla coating on the matrix coil.
  • 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.

Device

Boston Scientific brand Matrix2 Helical UltraSoft SR Coils
  • Model / Serial
    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
  • 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 Helical 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

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