FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538: 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.
- Recall number
- Z-0863-2011
- Recalling firm
- Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-10-19
- Posted
- 2011-01-05
- Terminated
- 2012-01-27
- Reason
- The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- 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
- 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.
- Lot, serial or model codes
- Material Product Description Catalog # Batch numbers Expiry Date 11252230,11308509,11314276,11325957, 11336598, 11393159, 11395513, 11407112, 11451244,11531641,11550997,11560540, 11591562,11591706,11622023,11658783, 11658785,11658822,11676148,11676157, 11719463, 11730234, 11790200, 11800701, 11800705,11820288,11850793,11850843, 11873434,11908088,11934094,11958442, 11958449,11958467,11975078,11975174, 12018396,12061956,12082830,12093269, 12102499, 12102571, 12112302, 12119035, M003498204SRO Matrix2¿ 360 UltraSoft SR Coils 498204-SR 12130177,12156608,12156619,12172635, Oct2010 through 2mm x4cm 12175697,12176083,12176088,12176096, Aug2013 12176113,12176130,12214865,12229603, 12229665,12229709,12300883,12304385, 12316893,12330638,12372623,12383765, 12388036,12498742,12514610,12549119, 12549517,12579004,12669973,12670052, 12702899,12703158,12721628,12748406, 12775526,12792905,12810367,12847198, 12856251,12861682,12861685,12861728, 12902495,12909257,12920788,12922010, 12922031,12947555,13165095,13182078, 13740728 11285904, 11325811, 11330308, 11336721, 11344686,11429308,11430218,11491190, 11535756,11551320,11580678,11586999, 11606468,11640887,11676151,11676165, Matrix2¿ 360 UltraSoft SR Coils 11792442,11820281,11820295,11850792, Oct2010 through M003498206SRO 498206-SR 11850844,12043227,12119036,12130803, 2mm x6cm 12130817,12194743,12229581,12229605, Jun2013 12299406,12304391,12514596,12549520, 12650936,12792884,12861539,12861681, 12861726,12929268,12947551,12982270, 13165082,13165102,13600453 11290821,11306854,11414844,11415101, 11488903,11524527,11535144,11598085, 11658796,11730211,11756822,11800379, 11850788,11873437,11889319,11889933, 11958235,11958447,11975073,11975199, 11992222,12009642,12043109,12082849, 12102496,12112306,12130249,12156604, Matrix2¿ 360 UltraSoft SR Coils 12156607,12156621,12172961,12175696, Oct2010 through M003498304SRO 498304-SR 12175827,12176080,12176086,12176101, 3mm x4cm 12229674,12229678,12304388,12315366, Jan2013 12330621,12368749,12370624,12374136, 12374221,12376353,12379817,12383766, 12514603,12541587,12549512,12549525, 12579028,12636755,12703154,12703190, 12748467,12792896,12861696,12902497, 12922003,12922028,12947530,13165085, 13165101,13198188,13204883,13230537 I 11302950,11385614,11385615,11403344, 11440497,11444540,11475012,11523684, 11552540,11591597,11598082,11622020, 11640889, 11676150, 11730057, 11730213, 11788744, 11820175, 11820292, 11836537, 11850840,11873438,11908089,11925597, 11958473,11975164,11975183,11992201, 12009563,12009573,12009640,12026744, 12043228, 12067385, 12082843, 12082859, Matrix2¿ 360 UltraSoft SR Coils 12112303,12127498,12142026,12142038, Oct2010 through M003498306SRO 498306-SR 12176131,12188229,12194499,12194715, 3mm x6cm 12194731,12214717,12214815,12214857, Aug2013 12229662, 12299405, 12304191, 12304196, 12368752,12388034,12396262,12418213, 12424869,12427988,12439191,12439351, 12549523,12636732,12636756,12670041, 12702896,12703155,12703187,12753182, 12783356,12792890,12792921,12858819, 12861684, 12861720, 12922011, 12929262, 13109928, 13165083, 13165093, 13606646, 13740721 11321963,11325815,11341602,11440812, 11444365, 11488901, 11489569, 11550743, 11560542, 11598086, 11658799, 11730230, 11788749,11820283,11850855,11916970, M003498308SRO Matrix2¿ 360 UltraSoft SR Coils 498308-SR 11958232, 11958238, 11958448, 11958466, Nov2010 through 3mm x8cm 11996497,12102567,12130806,12194700, Jun2013 12194723,12214852,12229590,12549509, 12578759,12636733,12810343, 12885370, 12918062,12942555,12946179,13118674, 13165108,13182069,13600456 11293279,11318108,11345092,11407741, 11489572,11538865,11580677,11586997, 11658786,11712101,11719464,11789879, 11792443, 11820170, 11820282, 11850856, 11889925,11958236,11958456,12021661, Matrix2¿ 360 UltraSoft SR Coils 12026495,12026742,12082848,12112305, Oct2010 through M003498406SRO 498406-SR 12141859,12142033,12186120,12194702, 4mm x6cm 12194724, 12214850, 12229704, 12295452, Jun2013 12296704,12315362,12330599, 12439225, 12514516,12549514,12570929, 12669968, 12670046,12779824,12792888, 12805886, 12899134,12922013,12947538,13112464, 13165107,13610468 . 11314326,11320203,11336864,11396043, 11444147,11444545,11489567,11523682, 11538870, 11552547, 11560546, 11591708, 11658820,11676163,11676203,11788743, 11820174, 11820287, 11850846, 11873436, 11925602,11938492,11975160,11975176, 11975222,11992210,12009652,12061958, 12074313,12082844,12102564,12110478, Matrix2¿ 360 UltraSoft SR Coils 12119835, 12130819, 12194486, 12194491, Oct2010 through M003498408SRO 498408-SR 12194701,12194717,12194737,12214191, 4mm x8cm 12214718,12214817,12299414,12300716, Jun2013 12304387, 12330612, 12330647, 12385409, 12409147,12413139,12424873,12424877, 12439196, 12439352, 12567224, 12579029, 12669005, 12703185, 12721626, 12748407, 12783357,12791150,12922015,12929076, 12929261,12947543,12982329,12982336, 13116525,13164430,13165087,13182068, 13182074, 13602977 11321964, 11322842, 11432824, 11485038, 11531649, 11591564, 11591700, 11676177, 11697470,11712102,11719465,11721430, 11820323,11889309,11889316,11916971, 11952857,12026496,12043224,12061790, 12115320,12119907,12130813,12142087, M003498510SRO Matrix2¿ 360 UltraSoft SR Coils 498510-SR 12194718,12214197,12214714,12214842, Nov2010 through 5mmx10cm 12267364, 12304383, 12311944, 12315361, Jun2013 12315363,12356259,12392931,12404359, 12418210, 12439358, 12549513, 12634217, 12703183,12748428,12791153,12792898, 12861694,12922006, 12929075, 13164428, 13164795,13165092,13195731,13200123, 13233310,13603121 11323634,11325812,11329547,11403547, 11552535,11591701,11711974,11711979, Matrix2¿ 360 UltraSoft SR Coils 11766679, 11838297, 11850794, 11908093, Nov2010 through M003498515SRO 498515-SR 11946180,11991286,12214846,12226292, 5mmx15cm 12229666,12306631,12446872,12468830, Oct2012 12495253,12514592,12523445, 12579019, 12810368,12914092,12946427,13113054 11281623, 11380106, 11552542, 11658791, Matrix2¿ 360 UltraSoft SR Coils 11748395,11889312,12061947,12115321, Oct2010 through M003498610SRO 498610-SR 12142031,12299316,12370621,12446874, 6mmx10cm 12514609,12632702,13118675,13165080, Aug2013 13740727 11322855, 11385261, 11486201, 11531652, Matrix2¿ 360 UltraSoft SR Coils 11591702,11658823,11697473,11800199, Nov2010 through M003498615SRO 498615-SR 12194497, 12214193, 12226290, 12229705, 6mmx15cm 12439187,12491070,12495248,12514597, Aug2013 12947527,12965255,13740729
- 510(k) numbers
- ["K012985","K031168"]
- PMA numbers
- not on file
- Product code
- HGC
- Firm FEI
- 2939204
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28