Z-0860-2011

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

Name: Z-0860-2011 Boston Scientific brand Matrix2 360 Standard 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 Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in... 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-0860-2011
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 Standard 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 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 .

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)