{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "96169",
      "product_res_number": "Z-0863-2011",
      "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 UltraSoft SR Coils. 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   11252230,11308509,11314276,11325957, \t \t\t\t11336598, 11393159, 11395513, 11407112, \t \t\t\t11451244,11531641,11550997,11560540, \t \t\t\t11591562,11591706,11622023,11658783, \t \t\t\t11658785,11658822,11676148,11676157, \t \t\t\t11719463, 11730234, 11790200, 11800701, \t \t\t\t11800705,11820288,11850793,11850843, \t \t\t\t11873434,11908088,11934094,11958442, \t \t\t\t11958449,11958467,11975078,11975174, \t \t\t\t12018396,12061956,12082830,12093269, \t \t\t\t12102499, 12102571, 12112302, 12119035, \t M003498204SRO \tMatrix2¿ 360 UltraSoft SR Coils \t498204-SR \t12130177,12156608,12156619,12172635, \tOct2010 through  \t2mm x4cm \t\t12175697,12176083,12176088,12176096, \tAug2013  \t\t\t12176113,12176130,12214865,12229603, \t \t\t\t12229665,12229709,12300883,12304385, \t \t\t\t12316893,12330638,12372623,12383765, \t \t\t\t12388036,12498742,12514610,12549119, \t \t\t\t12549517,12579004,12669973,12670052, \t \t\t\t12702899,12703158,12721628,12748406, \t \t\t\t12775526,12792905,12810367,12847198, \t \t\t\t12856251,12861682,12861685,12861728, \t \t\t\t12902495,12909257,12920788,12922010, \t \t\t\t12922031,12947555,13165095,13182078, \t \t\t\t13740728 \t \t\t\t11285904, 11325811, 11330308, 11336721, \t \t\t\t11344686,11429308,11430218,11491190, \t \t\t\t11535756,11551320,11580678,11586999, \t \t\t\t11606468,11640887,11676151,11676165, \t \tMatrix2¿ 360 UltraSoft SR Coils \t\t11792442,11820281,11820295,11850792, \tOct2010 through  M003498206SRO \t\t498206-SR \t11850844,12043227,12119036,12130803, \t \t2mm x6cm \t\t12130817,12194743,12229581,12229605, \tJun2013  \t\t\t12299406,12304391,12514596,12549520, \t \t\t\t12650936,12792884,12861539,12861681, \t \t\t\t12861726,12929268,12947551,12982270, \t \t\t\t13165082,13165102,13600453 \t \t\t\t11290821,11306854,11414844,11415101, \t \t\t\t11488903,11524527,11535144,11598085, \t \t\t\t11658796,11730211,11756822,11800379, \t \t\t\t11850788,11873437,11889319,11889933, \t \t\t\t11958235,11958447,11975073,11975199, \t \t\t\t11992222,12009642,12043109,12082849, \t \t\t\t12102496,12112306,12130249,12156604, \t \tMatrix2¿ 360 UltraSoft SR Coils \t\t12156607,12156621,12172961,12175696, \tOct2010 through  M003498304SRO \t\t498304-SR \t12175827,12176080,12176086,12176101, \t \t3mm x4cm \t\t12229674,12229678,12304388,12315366, \tJan2013  \t\t\t12330621,12368749,12370624,12374136, \t \t\t\t12374221,12376353,12379817,12383766, \t \t\t\t12514603,12541587,12549512,12549525, \t \t\t\t12579028,12636755,12703154,12703190, \t \t\t\t12748467,12792896,12861696,12902497, \t \t\t\t12922003,12922028,12947530,13165085, \t \t\t\t13165101,13198188,13204883,13230537 \t   I\t\t\t11302950,11385614,11385615,11403344, \t \t\t\t11440497,11444540,11475012,11523684, \t \t\t\t11552540,11591597,11598082,11622020, \t \t\t\t11640889, 11676150, 11730057, 11730213, \t \t\t\t11788744, 11820175, 11820292, 11836537, \t \t\t\t11850840,11873438,11908089,11925597, \t \t\t\t11958473,11975164,11975183,11992201, \t \t\t\t12009563,12009573,12009640,12026744, \t \t\t\t12043228, 12067385, 12082843, 12082859, \t \tMatrix2¿ 360 UltraSoft SR Coils \t\t12112303,12127498,12142026,12142038, \tOct2010 through  M003498306SRO \t\t498306-SR \t12176131,12188229,12194499,12194715, \t \t3mm x6cm \t\t12194731,12214717,12214815,12214857, \tAug2013  \t\t\t12229662, 12299405, 12304191, 12304196, \t \t\t\t12368752,12388034,12396262,12418213, \t \t\t\t12424869,12427988,12439191,12439351, \t \t\t\t12549523,12636732,12636756,12670041, \t \t\t\t12702896,12703155,12703187,12753182, \t \t\t\t12783356,12792890,12792921,12858819, \t \t\t\t12861684, 12861720, 12922011, 12929262, \t \t\t\t13109928, 13165083, 13165093, 13606646, \t \t\t\t13740721 \t \t\t\t11321963,11325815,11341602,11440812, \t \t\t\t11444365, 11488901, 11489569, 11550743, \t \t\t\t11560542, 11598086, 11658799, 11730230, \t \t\t\t11788749,11820283,11850855,11916970, \t M003498308SRO \tMatrix2¿ 360 UltraSoft SR Coils \t498308-SR \t11958232, 11958238, 11958448, 11958466, \tNov2010 through  \t3mm x8cm \t\t11996497,12102567,12130806,12194700, \tJun2013  \t\t\t12194723,12214852,12229590,12549509, \t \t\t\t12578759,12636733,12810343, 12885370, \t \t\t\t12918062,12942555,12946179,13118674, \t \t\t\t13165108,13182069,13600456 \t \t\t\t11293279,11318108,11345092,11407741, \t \t\t\t11489572,11538865,11580677,11586997, \t \t\t\t11658786,11712101,11719464,11789879, \t \t\t\t11792443, 11820170, 11820282, 11850856, \t \t\t\t11889925,11958236,11958456,12021661, \t \tMatrix2¿ 360 UltraSoft SR Coils \t\t12026495,12026742,12082848,12112305, \tOct2010 through  M003498406SRO \t\t498406-SR \t12141859,12142033,12186120,12194702, \t \t4mm x6cm \t\t12194724, 12214850, 12229704, 12295452, \tJun2013  \t\t\t12296704,12315362,12330599, 12439225, \t \t\t\t12514516,12549514,12570929, 12669968, \t \t\t\t12670046,12779824,12792888, 12805886, \t \t\t\t12899134,12922013,12947538,13112464, \t \t\t\t13165107,13610468 .\t \t\t\t11314326,11320203,11336864,11396043, \t \t\t\t11444147,11444545,11489567,11523682, \t \t\t\t11538870, 11552547, 11560546, 11591708, \t \t\t\t11658820,11676163,11676203,11788743, \t \t\t\t11820174, 11820287, 11850846, 11873436, \t \t\t\t11925602,11938492,11975160,11975176, \t \t\t\t11975222,11992210,12009652,12061958, \t \t\t\t12074313,12082844,12102564,12110478, \t \tMatrix2¿ 360 UltraSoft SR Coils \t\t12119835, 12130819, 12194486, 12194491, \tOct2010 through  M003498408SRO \t\t498408-SR \t12194701,12194717,12194737,12214191, \t \t4mm x8cm \t\t12214718,12214817,12299414,12300716, \tJun2013  \t\t\t12304387, 12330612, 12330647, 12385409, \t \t\t\t12409147,12413139,12424873,12424877, \t \t\t\t12439196, 12439352, 12567224, 12579029, \t \t\t\t12669005, 12703185, 12721626, 12748407, \t \t\t\t12783357,12791150,12922015,12929076, \t \t\t\t12929261,12947543,12982329,12982336, \t \t\t\t13116525,13164430,13165087,13182068, \t \t\t\t13182074, 13602977 \t \t\t\t11321964, 11322842, 11432824, 11485038, \t \t\t\t11531649, 11591564, 11591700, 11676177, \t \t\t\t11697470,11712102,11719465,11721430, \t \t\t\t11820323,11889309,11889316,11916971, \t \t\t\t11952857,12026496,12043224,12061790, \t \t\t\t12115320,12119907,12130813,12142087, \t M003498510SRO \tMatrix2¿ 360 UltraSoft SR Coils \t498510-SR \t12194718,12214197,12214714,12214842, \tNov2010 through  \t5mmx10cm \t\t12267364, 12304383, 12311944, 12315361, \tJun2013  \t\t\t12315363,12356259,12392931,12404359, \t \t\t\t12418210, 12439358, 12549513, 12634217, \t \t\t\t12703183,12748428,12791153,12792898, \t \t\t\t12861694,12922006, 12929075, 13164428, \t \t\t\t13164795,13165092,13195731,13200123, \t \t\t\t13233310,13603121 \t \t\t\t11323634,11325812,11329547,11403547, \t \t\t\t11552535,11591701,11711974,11711979, \t \tMatrix2¿ 360 UltraSoft SR Coils \t\t11766679, 11838297, 11850794, 11908093, \tNov2010 through  M003498515SRO \t\t498515-SR \t11946180,11991286,12214846,12226292, \t \t5mmx15cm \t\t12229666,12306631,12446872,12468830, \tOct2012  \t\t\t12495253,12514592,12523445, 12579019, \t \t\t\t12810368,12914092,12946427,13113054 \t \t\t\t11281623, 11380106, 11552542, 11658791, \t \tMatrix2¿ 360 UltraSoft SR Coils \t\t11748395,11889312,12061947,12115321, \tOct2010 through  M003498610SRO \t\t498610-SR \t12142031,12299316,12370621,12446874, \t \t6mmx10cm \t\t12514609,12632702,13118675,13165080, \tAug2013  \t\t\t13740727 \t \t\t\t11322855, 11385261, 11486201, 11531652, \t \tMatrix2¿ 360 UltraSoft SR Coils \t\t11591702,11658823,11697473,11800199, \tNov2010 through  M003498615SRO \t\t498615-SR \t12194497, 12214193, 12226290, 12229705, \t \t6mmx15cm \t\t12439187,12491070,12495248,12514597, \tAug2013  \t\t\t12947527,12965255,13740729",
      "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": {
        "device_name": "Clamp, Uterine",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4520",
        "device_class": "1",
        "registration_number": [
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}