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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific brand Matrix2 360 Standard SR Coils.

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  Class 2 Device Recall Boston Scientific brand Matrix2 360 Standard SR Coils. see related information
Date Initiated by Firm October 19, 2010
Date Posted January 05, 2011
Recall Status1 Terminated 3 on January 27, 2012
Recall Number Z-0860-2011
Recall Event ID 57179
510(K)Number K031168  K012985  
Product Classification vascular embolization device - Product Code HGC
Product Boston Scientific brand Matrix2 360 Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
Code Information Material Product Description Catalog # Batch numbers Expiry Date    11322013,11341317,11395760,11407118,   11484317,11500845,11538872,11580676,   11586996,11591704,11676172,11786207,   11800707,11843132,11889308,11889310,   11924294, 11946182, 11975161, 11975197,   Matrix2¿ 360 Standard SR Coils 12000345,12119829,12127493,12156626, Nov2010 through  M003492103SRO 492103-SR 12176110, 12194735, 12214709, 12214800,   10mm x 30cm 12214853, 12229661, 12291690, 12299408, Jun2013   12315367,12330591,12409146,12418207,   12439180,12439189,12514594,12669964,   12670044,12703195,12791152,12792881,   12863906,12909368,12913888,12921982,   13165100,13182071,13602875   11296519,11329483,11422711,11477789,   11606464,11711221,11712103,11786210,   11908091,11924295,11940396,11975180,   11996498,12009649,12112236,12119825,   Matrix2¿ 360 Standard SR Coils 12141857,12156617,12214707,12214715, Oct2010 through  M003492123SRO 492123-SR 12214861,12291695,12295742,12314469,   12mm x 30cm 12392928,12401322,12458011,12462033, Jun2013   12519869, 12523479, 12669970, 12810344,   12861691,12912140,12920952,12921980,   12921996,12982276,13164798,13165084,   13603462   Matrix2¿ 360 Standard SR Coils 11286172,11327021,11552550,11756832, Oct2010 through  M003492308SRO 492308-SR 11792451,12082838,12194728,12494078,   3mm x8cm 12947522 Aug2012   11310925,11340517,11513571,11598083,   11748422,11820289,11850852,11924296,   11940398,11975077,12007427,12026497,   Matrix2¿ 360 Standard SR Coils 12026741,12074031,12074306,12110477, Oct2010 through  M003492408SRO 492408-SR 12130818,12142084,12156609,12176095,   4mm x8cm 12176129,12214851,12304396,12418211, Dec2012   12434605, 12439350, 12579013, 12702894,   12721623,12792899,12810370,12917824,   12947545, 13164799   11289583,11341604,11500842,11622022,  M003492510SRO Matrix2¿ 360 Standard SR Coils 492510-SR 11730241, 11786201, 11820321, 12194490, Oct2010 through   5mm x 10cm 12214705, 12434606, 12450913, 12465570, Aug2012   12922017   11299199,11318111,11389194,11500843,   11550742,11606466,11697460,11711220,   11748398,11838629,11889318,11916974,   11958443,11958463,11984850,12043111,   12061948,12082851,12086034,12142091,  M003492515SRO Matrix2¿ 360 Standard SR Coils 492515-SR 12150131,12176136,12188226,12194738, Oct2010 through   5mmx15cm 12214194,12225443,12229718,12330640, Aug2013   12361044,12378759,12383763,12431052,   12439197, 12636726, 12656660, 12792894,   12805887,12861538,12861680,12899138,   12921993,12922024,12929260,12982324,   13164797,13182067,13197169,13740709   Matrix2¿ 360 Standard SR Coils 11300189,11697441,11748423,12102562, Oct2010 through  M003492610SRO 492610-SR 12194744,12650932,13109926,13201013,   6mm x 10cm 13220484 Dec2012   11281622,11311916,11314681,11491189,   11521070, 11591707, 11676160, 11730225,   11766704,11838625,11934378,11958468,   11975166,11975191,11992203,11992212,   12009577,12009653,12082842,12130810,   Matrix2¿ 360 Standard SR Coils 12142036,12161320,12168019,12176126, Oct2010 through  M003492615SRO 492615-SR 12214841,12229589,12300888,12330615,   6mmx15cm 12379816, 12388035,12409150,12427992, Dec2012   12439353, 12519870, 12549504, 12549518,   12636727, 12670053, 12721624, 12748411,   12791149, 12792892, 12861690, 12889253,   12912271,12922000,12947541,12982277,   13016751,13165091   Matrix2¿ 360 Standard SR Coils 11311649,11552534,11697440,11697450, Oct2010 through  M003492715SRO 7mm x 15cm 492715-SR 11766703,12176124,12229551,12372622, Dec2012   12494180,12698228,12922016,13201014 11325958,11330877,11448223,11516241,   11591599, 11640896, 11676142, 11676149,   11766671, 11786209, 11795499, 11820176,   11868816,11925596,11975072,11975182,   11992202,11992218,12009562,12009570,  M003492720SRO Matrix2¿ 360 Standard SR Coils 492720-SR 12051397,12082854,12142030,12188227, Nov2010 through   7mm x20cm 12194711,12194747,12214845,12225440, Jul2013   12291691,12299412,12314471,12324046,   12355111,12401321,12409152,12418208,   12427990,12636754,12810346,12841940,   12861722, 12917822, 12922005, 12947520,   12947528, 13165089, 13705204   11303726, 11344541, 11491183, 11597978,   11697453,11730059,11766677,11800708,  M003492820SRO Matrix2¿ 360 Standard SR Coils 492820-SR 11836538,11838623,11958239,12043226, Oct2010 through   8mm x20cm 12130809,12194736,12260123,12388030, Jun2013   12669969, 12791148, 12792880, 12922002,   13201015, 13202909, 13606213   11310595,11410936,11470446,11552546,   11606467,11658788,11712109,11766665,   11800187,11838294,11869782,11925588,   11975179,11992216,12009571,12043110,   Matrix2¿ 360 Standard SR Coils 12061953, 12069212, 12074311, 12119903, Oct2010 through  M003492830SRO 492830-SR 12150137,12188230,12194489,12194704,   8mm x30cm 12229669, 12291686, 12296707, 12314472, Dec2012   12330585,12356257,12361056,12636753,   12669979, 12703142, 12753169, 12783354,   12792913, 12895634, 12899136, 12912676,   12922009,13165096  .,tl003492920SRO Matrix2¿ 360 Standard SR Coils 492920-SR 11318113,11441724,11542877,11711222, Nov2010 through   9mm x20cm 11838626,12150132,12579018,13614169 Jun2013   11290201,11318378,11403946,11488185,   11520165,11598081,11658797,11748390,   11889313,11940587,11952858,12009643,   12026498,12061945,12069211,12074037,   Matrix2¿ 360 Standard SR Coils 12130804,12176121,12194485,12194498, Oct2010 through  M003492930SRO 492930-SR 12194734,12229597,12295451,12296708,   9mm x 30cm 12325703,12355110,12549418,12549503, Aug2013   12564285,12579005,12589397,12656661,   12669971,12792539,12792897,12853506,   12861697,12891631,12922012,12982278,   13182063, 13204832, 13740457 .      
Recalling Firm/
Manufacturer		 Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Robert Ware
510-624-2544
Manufacturer Reason
for Recall		 The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HGC and Original Applicant = BOSTON SCIENTIFIC, TARGET
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