Events

Recall of Boston Scientific brand Matrix2 360 Soft 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-0859-2011
  • 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=96011
  • 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 360 Soft SR Coils.
  • Model / Serial
    Material Product Description Catalog # Batch numbers Expiry Date    11327721,11504445,11552548,11598084,   Matrix2 360 Soft SR Coils 3mm 11658821,11992209,12061946,12074034, Nov2010 through  M003490304SRO 490304-SR 12142090,12194733,12229550,12260121,   x4cm 12439221,12514518,12570927,12579017, Aug2012   12792914, 12899133   11249858,11314331,11340645,11474490,   11552544,11598080,11658789,11712104,   11730236,11748424,11829804,11850851,   11889315,11924291,11958451,11991899,   11992200,12009564,12061951,12067387,   12074300,12119830,12119908,12142037,   Matrix2 360 Soft SR Coils 3mm 12186121,12194487,12194492,12194709, Oct2010 through  ,1003490306SRO 490306-SR 12194729,12214847,12229676,12291688,   x6cm 12311954,12315364,12317008,12404354, Dec2012   12431055,12439440,12465571,12514602,   12636739,12670100,12698231,12721495,   12748470,12792883,12810371,12856503,   12861688,12874522,12922027,12929077,   12982322,13164432,13164796,13165110,   13204836   11391994,11451245,11497223,11560544,   11622024,11697452,11697465,11730229,   11790203,11820285,11889311,12009567,   12009651,12043116,12061789,12067386,   12074308,12119826,12119905,12141858,   12142023,12142080,12194713,12194748,  M003490308SRO Matrix2 360 Soft SR Coils 3mm 490308-SR 12229543,12229557,12291689,12311955, Dec2010 through   x8cm 12388033,12401320,12418209,12514601, Aug2013   12549500,12549515,12579001,12579011,   12636731,12669965,12669977,12695189,   12698227,12748429,12783352,12792903,   12861733,12878386,12922007,12947549,   12982323,12982331,13108353,13165103,   13611875,13740715   11248431,11435810,11488182,11538866,   11560545,11580674,11586995,11790201,   11820178,11850847,11873431,11925605,   11940385, 11975165, 11975196, 11992221,   12043112,12102495,12102570,12130816,   Matrix2 360 Soft SR Coils 4mm 12141856,12142021,12156618,12176087, Oct2010 through  M003490406SRO 490406-SR 12176123,12214854,12267374,12320493,   x6cm 12324045,12330630,12358025,12376354, Dec2012   12401323, 12404357, 12427985, 12434604,   12446873,12579365,12589398,12636758,   12669962,12669976,12703153,12810347,   12861698,12903423,12922029,12947553,   13016331, 13165116   11293329,11378006,11388501,11399189,   11435809,11440484,11486119,11535146,   11552543,11560543,11597979,11622027,   11658787,11676144,11676159,11718824,   11873435,11889920,11908086,11958455,   11975069,11975169,11992215,12009576,   12009646,12026499,12043220,12061955,   12082847,12119839,12130814,12142089,   12156612,12156625,12175821,12176089,   12176103,12176120,12214807,12214856,   Matrix2 360 Soft SR Coils 4mm 12225445,12226291,12228156,12260124, Oct2010 through  M003490408SRO 490408-SR 12330661,12370631,12372625,12374139,   x8cm 12377446,12388031,12439195,12439232, Jun2013   12465567, 12474440, 12474444, 12495244,   12514511,12514582,12514604,12553672,   12567223, 12570928, 12582206, 12636730,   12636747, 12670043, 12688725, 12703180,   12753145,12753168,12792891,12792918,   12856252,12861683,12861699,12882522,   12909275,12922001,12947529,12947548,   12981235,12982325,12982333,13113667,   13164429,13165088,13165106,13204887,   13614550   11241568,11295953,11318655,11388824,   11418198,11418199,11516242,11552539,   11598087,11676147,11756825,11838296,   11838633,11869781,11889923,11925601,   11940383,11963587,11975076,11975177,   11992204, 11992211, 12009654, 12047550,   12102498,12102572,12112301,12127497,   12142022,12142032,12161233,12194719,  M003490510SRO Matrix2 360 Soft SR Coils 5mm 490510-SR 12194746,12210213,12228826,12229587, Oct2010 through   x 10cm 12330645, 12368750, 12370623, 12379815, Aug2013   12427984, 12434603, 12465569, 12495250,   12549419,12549506,12549519,12577901,   12579023,12669966,12669974,12698233,   12703157,12703197,12792900,12810352,   12859278, 12861729, 12902494, 12914299,   12921998, 12947534, 12982326, 12982334,   13016338,13026037,13115713,13165098,   13182062,13190678,13740723     11241926,11323157,11388508,11411633,   11472604,11497222,11497859,11552549,   11606463,11640894,11676145,11721432,   11756827,11820291,11850795,11869792,   11889924,11938493,11940586,11963588,   11967351,11975074,11975172,12000344,   12018387,12047344,12102497,12110476,   12112237,12127025,12142024,12142083,   12161228,12194730,12214802,12214859,  M003490515SRO Matrix2 360 Soft SR Coils 5mm 490515-SR 12229580,12260120,12300881,12306629, Oct2010 through   x 15cm 12315370,12325704,12330628,12358024, Dec2012   12388029,12392932,12404351,12404358,   12409148,12413361,12424871,12434608,   12439355,12579003,12632701,12669001,   12670051,12698225,12703147,12703181,   12721620,12721636,12792915,12810345,   12810362,12856010,12861695,12888522,   12909744,12920953, 12921984, 12922004,   12929263,12982271,13165090,13165119,   13182076   11299320,11329549,11340642,11489571,   11552541,11712108,11721431,11748391,   11869789,11908094,11963589,11967349,   11975170,12061949,12074316,12141375,   12156611,12169000,12176013,12176090,  M003490610SRO Matrix2 360 Soft SR Coils 6mm 490610-SR 12214809,12259818,12291684,12295456, Oct2010 through   x 10cm 12311956,12330632,12378758,12392930, Jan2013   12401019,12404355,12404521,12424874,   12431054,12431056,12434610,12579027,   12669978,12792895,12918642,12947544,   12982272,12990294,13016325,13113185,   13164431,13182075,13233311   11319664,11344931,11404790,11491182,   11535755, 11552536, 11591703, 11606465,   11658794,11676146,11766676,11800186,   11838299,11850782,11850790,11850850,   11889929,11924290,11934376,11975181,   11992205,12009572,12009647,12061952,   12067384,12074309,12074310,12119828,   12119837,12130808,12142039,12187530,  M003490615SRO Matrix2 360 Soft SR Coils 6mm 490615-SR 12194495,12194712,12194740,12214819, Nov2010 through   x 15cm 12299317,12299410,12306630,12315369, Sep2012   12356256,12358026,12401293,12404352,   12404356, 12413360, 12413362, 12424875,   12434602,12439442,12577739,12579015,   12632700,12669000,12670054,12703188,   12721627,12748472,12810341,12810348,   12838009, 12849284, 12860900, 12861724,   12903859,12906596,12921997,12922014,   12981467, 13015393, 13016327   Matrix2 360 Soft SR Coils 7mm 11396531,11552538,11766668,11992206, Dec2010 through  M003490710SRO 490710-SR 12074303, 12259819, 12370622, 12431053,   x 10cm 12964403 Aug2012     11247286,11330876,11399084,11520021,   11591598,11697443,11697461,11730232,   11756828,11916973,11991893,12026494,   12047549,12051396,12119832,12168018,   12188228,12194707,12194754,12214195,  M003490715SRO Matrix2 360 Soft SR Coils 7mm 490715-SR 12225279,12291685,12296703,12315365, Oct2010 through   x 15cm 12330625,12356320,12365840,12392933, Aug2013   12404522,12409149,12434607,12439356,   12549524,12579012,12636741,12670048,   12783355,12810342,12912905,12922030,   12982327,12982335,13182064,13202907,   13740724   11377048,11388828,11433319,11475013,   11491419,11497447,11560339,11697464,   11730226, 11748420, 11756830, 11829805,  M003490720SRO Matrix2 360 Soft SR Coils 7mm 490720-SR 11838635, 11908085, 11985698, 12102494, Dec2010 through   x20cm 12102565,12127495,12161470,12214855, Dec2012   12228403,12519871,12549526,12703220,   12791151,12792885,12917401,12982273,   13164433,13174305   11249122,11307527,11396327,11521506,   11552545,11622021,11712106,11748392,   11756831,11850798,11869806,11940395,   11963590,11975175,12018395,12061950,   12082824,12102573,12130175,12155990,  M003490820SRO Matrix2 360 Soft SR Coils 8mm 490820-SR 12176091,12176132,12214706,12214712, Oct2010 through   x20cm 12214848,12295450,12295454,12296712, Dec2012   12296713,12304194,12304198,12330636,   12358027,12364673,12474441,12514599,   12577900, 12636735, 12792882, 12922025,   12982274,13016323,13115792,13164434,   13182066   11342412,11475011,11504449,11543008,   11560541, 11658790, 11676153, 11790202,  M003490830SRO Matrix2 360 Soft SR Coils 8mm 490830-SR 11850783, 11850796,11946181,12047553, Nov2010 through   x30cm 12119902,12214863,12225442,12229613, Dec2012   12567225, 12636736,12906335,12947546,   13019231,13164435,13181899,13190677
  • 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 Soft 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