Z-0859-2011

Boston Scientific brand Matrix2 360 Soft SR Coils. Intended for embolization of certain intracranial...

Name: Z-0859-2011 Boston Scientific brand Matrix2 360 Soft SR Coils. Intended for embolization of certain intracranial...
Creator: Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
Published: 2010-10-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-10-19 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 began a recall of Boston Scientific brand Matrix2 360 Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the... on 2010-10-19. The reason FDA records is "The product appears to have premature degradation of the PGLA coating on the Matrix Coil". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0859-2011
Status: Terminated
Initiated: 2010-10-19
Posted: 2011-01-05
Terminated: 2012-01-27
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: HGC Clamp, Uterine
Reason for recall: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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 code HGC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)