{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "96011",
      "product_res_number": "Z-0859-2011",
      "event_date_initiated": "2010-10-19",
      "event_date_posted": "2011-01-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-01-27",
      "res_event_number": "57179",
      "product_code": "HGC",
      "k_numbers": [
        "K012985",
        "K031168"
      ],
      "product_description": "Boston Scientific brand Matrix2 360 Soft SR Coils.\n Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.",
      "code_info": "Material \tProduct Description Catalog #  Batch numbers Expiry Date   \t\t\t11327721,11504445,11552548,11598084, \t \tMatrix2 360 Soft SR Coils 3mm \t\t11658821,11992209,12061946,12074034, \tNov2010 through  M003490304SRO \t\t490304-SR \t12142090,12194733,12229550,12260121, \t \tx4cm \t\t12439221,12514518,12570927,12579017, \tAug2012  \t\t\t12792914, 12899133 \t \t\t\t11249858,11314331,11340645,11474490, \t \t\t\t11552544,11598080,11658789,11712104, \t \t\t\t11730236,11748424,11829804,11850851, \t \t\t\t11889315,11924291,11958451,11991899, \t \t\t\t11992200,12009564,12061951,12067387, \t \t\t\t12074300,12119830,12119908,12142037, \t \tMatrix2 360 Soft SR Coils 3mm \t\t12186121,12194487,12194492,12194709, \tOct2010 through  ,1003490306SRO \t\t490306-SR \t12194729,12214847,12229676,12291688, \t \tx6cm \t\t12311954,12315364,12317008,12404354, \tDec2012  \t\t\t12431055,12439440,12465571,12514602, \t \t\t\t12636739,12670100,12698231,12721495, \t \t\t\t12748470,12792883,12810371,12856503, \t \t\t\t12861688,12874522,12922027,12929077, \t \t\t\t12982322,13164432,13164796,13165110, \t \t\t\t13204836 \t \t\t\t11391994,11451245,11497223,11560544, \t \t\t\t11622024,11697452,11697465,11730229, \t \t\t\t11790203,11820285,11889311,12009567, \t \t\t\t12009651,12043116,12061789,12067386, \t \t\t\t12074308,12119826,12119905,12141858, \t \t\t\t12142023,12142080,12194713,12194748, \t M003490308SRO \tMatrix2 360 Soft SR Coils 3mm \t490308-SR \t12229543,12229557,12291689,12311955, \tDec2010 through  \tx8cm \t\t12388033,12401320,12418209,12514601, \tAug2013  \t\t\t12549500,12549515,12579001,12579011, \t \t\t\t12636731,12669965,12669977,12695189, \t \t\t\t12698227,12748429,12783352,12792903, \t \t\t\t12861733,12878386,12922007,12947549, \t \t\t\t12982323,12982331,13108353,13165103, \t \t\t\t13611875,13740715 \t \t\t\t11248431,11435810,11488182,11538866, \t \t\t\t11560545,11580674,11586995,11790201, \t \t\t\t11820178,11850847,11873431,11925605, \t \t\t\t11940385, 11975165, 11975196, 11992221, \t \t\t\t12043112,12102495,12102570,12130816, \t \tMatrix2 360 Soft SR Coils 4mm \t\t12141856,12142021,12156618,12176087, \tOct2010 through  M003490406SRO \t\t490406-SR \t12176123,12214854,12267374,12320493, \t \tx6cm \t\t12324045,12330630,12358025,12376354, \tDec2012  \t\t\t12401323, 12404357, 12427985, 12434604, \t \t\t\t12446873,12579365,12589398,12636758, \t \t\t\t12669962,12669976,12703153,12810347, \t \t\t\t12861698,12903423,12922029,12947553, \t \t\t\t13016331, 13165116 \t \t\t\t11293329,11378006,11388501,11399189, \t \t\t\t11435809,11440484,11486119,11535146, \t \t\t\t11552543,11560543,11597979,11622027, \t \t\t\t11658787,11676144,11676159,11718824, \t \t\t\t11873435,11889920,11908086,11958455, \t \t\t\t11975069,11975169,11992215,12009576, \t \t\t\t12009646,12026499,12043220,12061955, \t \t\t\t12082847,12119839,12130814,12142089, \t \t\t\t12156612,12156625,12175821,12176089, \t \t\t\t12176103,12176120,12214807,12214856, \t \tMatrix2 360 Soft SR Coils 4mm \t\t12225445,12226291,12228156,12260124, \tOct2010 through  M003490408SRO \t\t490408-SR \t12330661,12370631,12372625,12374139, \t \tx8cm \t\t12377446,12388031,12439195,12439232, \tJun2013  \t\t\t12465567, 12474440, 12474444, 12495244, \t \t\t\t12514511,12514582,12514604,12553672, \t \t\t\t12567223, 12570928, 12582206, 12636730, \t \t\t\t12636747, 12670043, 12688725, 12703180, \t \t\t\t12753145,12753168,12792891,12792918, \t \t\t\t12856252,12861683,12861699,12882522, \t \t\t\t12909275,12922001,12947529,12947548, \t \t\t\t12981235,12982325,12982333,13113667, \t \t\t\t13164429,13165088,13165106,13204887, \t \t\t\t13614550 \t \t\t\t11241568,11295953,11318655,11388824, \t \t\t\t11418198,11418199,11516242,11552539, \t \t\t\t11598087,11676147,11756825,11838296, \t \t\t\t11838633,11869781,11889923,11925601, \t \t\t\t11940383,11963587,11975076,11975177, \t \t\t\t11992204, 11992211, 12009654, 12047550, \t \t\t\t12102498,12102572,12112301,12127497, \t \t\t\t12142022,12142032,12161233,12194719, \t M003490510SRO \tMatrix2 360 Soft SR Coils 5mm \t490510-SR \t12194746,12210213,12228826,12229587, \tOct2010 through  \tx 10cm \t\t12330645, 12368750, 12370623, 12379815, \tAug2013  \t\t\t12427984, 12434603, 12465569, 12495250, \t \t\t\t12549419,12549506,12549519,12577901, \t \t\t\t12579023,12669966,12669974,12698233, \t \t\t\t12703157,12703197,12792900,12810352, \t \t\t\t12859278, 12861729, 12902494, 12914299, \t \t\t\t12921998, 12947534, 12982326, 12982334, \t \t\t\t13016338,13026037,13115713,13165098, \t \t\t\t13182062,13190678,13740723 \t   \t\t\t11241926,11323157,11388508,11411633, \t \t\t\t11472604,11497222,11497859,11552549, \t \t\t\t11606463,11640894,11676145,11721432, \t \t\t\t11756827,11820291,11850795,11869792, \t \t\t\t11889924,11938493,11940586,11963588, \t \t\t\t11967351,11975074,11975172,12000344, \t \t\t\t12018387,12047344,12102497,12110476, \t \t\t\t12112237,12127025,12142024,12142083, \t \t\t\t12161228,12194730,12214802,12214859, \t M003490515SRO \tMatrix2 360 Soft SR Coils 5mm \t490515-SR \t12229580,12260120,12300881,12306629, \tOct2010 through  \tx 15cm \t\t12315370,12325704,12330628,12358024, \tDec2012  \t\t\t12388029,12392932,12404351,12404358, \t \t\t\t12409148,12413361,12424871,12434608, \t \t\t\t12439355,12579003,12632701,12669001, \t \t\t\t12670051,12698225,12703147,12703181, \t \t\t\t12721620,12721636,12792915,12810345, \t \t\t\t12810362,12856010,12861695,12888522, \t \t\t\t12909744,12920953, 12921984, 12922004, \t \t\t\t12929263,12982271,13165090,13165119, \t \t\t\t13182076 \t \t\t\t11299320,11329549,11340642,11489571, \t \t\t\t11552541,11712108,11721431,11748391, \t \t\t\t11869789,11908094,11963589,11967349, \t \t\t\t11975170,12061949,12074316,12141375, \t \t\t\t12156611,12169000,12176013,12176090, \t M003490610SRO \tMatrix2 360 Soft SR Coils 6mm \t490610-SR \t12214809,12259818,12291684,12295456, \tOct2010 through  \tx 10cm \t\t12311956,12330632,12378758,12392930, \tJan2013  \t\t\t12401019,12404355,12404521,12424874, \t \t\t\t12431054,12431056,12434610,12579027, \t \t\t\t12669978,12792895,12918642,12947544, \t \t\t\t12982272,12990294,13016325,13113185, \t \t\t\t13164431,13182075,13233311 \t \t\t\t11319664,11344931,11404790,11491182, \t \t\t\t11535755, 11552536, 11591703, 11606465, \t \t\t\t11658794,11676146,11766676,11800186, \t \t\t\t11838299,11850782,11850790,11850850, \t \t\t\t11889929,11924290,11934376,11975181, \t \t\t\t11992205,12009572,12009647,12061952, \t \t\t\t12067384,12074309,12074310,12119828, \t \t\t\t12119837,12130808,12142039,12187530, \t M003490615SRO \tMatrix2 360 Soft SR Coils 6mm \t490615-SR \t12194495,12194712,12194740,12214819, \tNov2010 through  \tx 15cm \t\t12299317,12299410,12306630,12315369, \tSep2012  \t\t\t12356256,12358026,12401293,12404352, \t \t\t\t12404356, 12413360, 12413362, 12424875, \t \t\t\t12434602,12439442,12577739,12579015, \t \t\t\t12632700,12669000,12670054,12703188, \t \t\t\t12721627,12748472,12810341,12810348, \t \t\t\t12838009, 12849284, 12860900, 12861724, \t \t\t\t12903859,12906596,12921997,12922014, \t \t\t\t12981467, 13015393, 13016327 \t \tMatrix2 360 Soft SR Coils 7mm \t\t11396531,11552538,11766668,11992206, \tDec2010 through  M003490710SRO \t\t490710-SR \t12074303, 12259819, 12370622, 12431053, \t \tx 10cm \t\t12964403 \tAug2012    \t\t\t11247286,11330876,11399084,11520021, \t \t\t\t11591598,11697443,11697461,11730232, \t \t\t\t11756828,11916973,11991893,12026494, \t \t\t\t12047549,12051396,12119832,12168018, \t \t\t\t12188228,12194707,12194754,12214195, \t M003490715SRO \tMatrix2 360 Soft SR Coils 7mm \t490715-SR \t12225279,12291685,12296703,12315365, \tOct2010 through  \tx 15cm \t\t12330625,12356320,12365840,12392933, \tAug2013  \t\t\t12404522,12409149,12434607,12439356, \t \t\t\t12549524,12579012,12636741,12670048, \t \t\t\t12783355,12810342,12912905,12922030, \t \t\t\t12982327,12982335,13182064,13202907, \t \t\t\t13740724 \t \t\t\t11377048,11388828,11433319,11475013, \t \t\t\t11491419,11497447,11560339,11697464, \t \t\t\t11730226, 11748420, 11756830, 11829805, \t M003490720SRO \tMatrix2 360 Soft SR Coils 7mm \t490720-SR \t11838635, 11908085, 11985698, 12102494, \tDec2010 through  \tx20cm \t\t12102565,12127495,12161470,12214855, \tDec2012  \t\t\t12228403,12519871,12549526,12703220, \t \t\t\t12791151,12792885,12917401,12982273, \t \t\t\t13164433,13174305 \t \t\t\t11249122,11307527,11396327,11521506, \t \t\t\t11552545,11622021,11712106,11748392, \t \t\t\t11756831,11850798,11869806,11940395, \t \t\t\t11963590,11975175,12018395,12061950, \t \t\t\t12082824,12102573,12130175,12155990, \t M003490820SRO \tMatrix2 360 Soft SR Coils 8mm \t490820-SR \t12176091,12176132,12214706,12214712, \tOct2010 through  \tx20cm \t\t12214848,12295450,12295454,12296712, \tDec2012  \t\t\t12296713,12304194,12304198,12330636, \t \t\t\t12358027,12364673,12474441,12514599, \t \t\t\t12577900, 12636735, 12792882, 12922025, \t \t\t\t12982274,13016323,13115792,13164434, \t \t\t\t13182066 \t \t\t\t11342412,11475011,11504449,11543008, \t \t\t\t11560541, 11658790, 11676153, 11790202, \t M003490830SRO \tMatrix2 360 Soft SR Coils 8mm \t490830-SR \t11850783, 11850796,11946181,12047553, \tNov2010 through  \tx30cm \t\t12119902,12214863,12225442,12229613, \tDec2012  \t\t\t12567225, 12636736,12906335,12947546, \t \t\t\t13019231,13164435,13181899,13190677",
      "firm_fei_number": "2939204",
      "recalling_firm": "Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538",
      "address_1": "47900 Bayside Pkwy",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538-6515",
      "additional_info_contact": "Robert Ware\n510-624-2544",
      "reason_for_recall": "The product appears to have premature degradation of the PGLA coating on the Matrix Coil.",
      "root_cause_description": "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.",
      "product_quantity": "77,364 total units",
      "distribution_pattern": "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.",
      "openfda": {
        "k_number": [
          "K771344",
          "K891402"
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        "device_name": "Clamp, Uterine",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4520",
        "device_class": "1",
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}