FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538: Boston Scientific brand Matrix2 360 Firm Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
- Recall number
- Z-0861-2011
- Recalling firm
- Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
- Product
- Boston Scientific brand Matrix2 360 Firm 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 Matrix2¿ 360 Firm Coils 1 Omm x 11252548,11403351,11513899,11552537, Oct2010 through M0034941 030 494103 11640881,12009568,12102561,12229607, 30cm 12365838, 12366382 Jan2012 M0034941230 Matrix2¿ 360 Firm Coils 12mm x 494123 11560338,11766417,11782395,11925586, Feb2011 through 30cm 12026743, 12316656, 12636596 Apr2012 11244766,11336915,11456769,11484774, M0034941430 Matrix2¿ 360 Firm Coils 14mm x 494143 11526777, 11766660, 11850791, 11958233, Oct2010 through 30cm 11958454,12317003,12396265,12753164, Jan2013 13165081,13182077,13230095 11253266,11336717,11454608,11489048, M0034941630 Matrix2¿ 360 Firm Coils 16mm x 494163 11526778,11697444,11697471,11958444, Oct2010 through 30cm 12176133,12214864,12319343,12396264, Dec2012 12859706, 13194482 11385269,11389724,11454839,11498643, M0034941 830 Matrix2¿ 360 Firm Coils 18mm x 494183 11609723,11766661,11869780,11958440, Dec2010 through 30cm 12036898,12225706,12316657,12365837, Aug2012 12396263, 12854017, 12929266 Matrix2¿ 360 Firm Coils 20mm x 11330476,11483884,11526779,11697442, Nov2010 through M0034942030 494203 11766414,11766673,11958234,11999799, 30cm 12194742,12317006,12753163,12859707 Jul2012 11252232,11380482,11551322,11785187, 11785188,11785190,11785191,11785192, M0034942440 Matrix2¿ 360 Firm Coils 24mm x 494244 11785193,11785194,11785195,11813607, Oct2010 through 40cm 11813608,11813609,11813610,11850841, Jul2012 12176108,12316654,12395388,12395420, 12428559,12429040,12841941,12861721 M0034945150 Matrix2¿ 360 Firm Coils 5mm x 494515 12214867,12636725 Oct2011 through 15cm Apr2012 M00349461 50 Matrix2¿ 360 Firm Coils 6mm x 494615 11340651,11474492,11958445 Nov2010 through 15cm Jul2011 M0034947200 Matrix2¿ 360 Firm Coils 7mm x 494720 11338767,11697459 Nov2010 through 20cm Apr2011 M0034948300 Matrix2¿ 360 Firm Coils 8mm x 494830 11488191,11850853,12000340 Jan2011 through 30cm Aug2011 M0034949300 Matrix2¿ 360 Firm Coils 9mm x 494930 11327025,11697448,11838298,11958230, Nov2010 through 30cm 12365839,12367860 Jan2012
- 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