FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538: Boston Scientific brand Matrix 2D Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
- Recall number
- Z-0856-2011
- Recalling firm
- Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
- Product
- Boston Scientific brand Matrix 2D Soft 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 M003471304SRO Matrix2¿ 2D Soft SR Coils 3mm 471304-SR 11391991,11697446,11721433,11775115, Dec2010 through x4cm 12579020 Mar2012 M003471306SRO Matrix2¿ 2D Soft SR Coils 3mm 471306-SR 11498868,11775116,12194493,12385403, Jan2011 through x6cm 12520966, 12861735 Jul2012 M003471308SRO Matrix2¿ 2D Soft SR Coils 3mm 471308-SR 11481348,11792449,11820171,12401292, Jan2011 through x8cm 12514514, 12792920 Jun2012 M003471310SRO Matrix2¿ 2D Soft SR Coils 3mm 471310-SR 11342011,11634830,12390151,12439220, Nov2010 through x 10cm 12982264 Sep2012 M003471406SRO Matrix2¿ 2D Soft SR Coils 4mm 471406-SR 11502704,11641203,12081496,12474445, Jan2011 through x6cm 12795286 Jun2012 11622088,11718835,11869785,11925599, 11940238,11985921,11992220,12156354, M003471408SRO Matrix2¿ 2D Soft SR Coils 4mm 471408-SR 12156603,12176007,12176017,12194725, Mar2011 through x8cm 12295449,12356324,12356325,12514591, Dec2012 12636738,12748405,12748465,12845925, 12891630,12906595,13200124 Matrix2¿ 2D Soft SR Coils 4mm 11310206,11552557,11766672,12119904, Oct2010 through M003471410SRO 471410-SR 12161473,12409142,12439231,12791147, x 10cm 12792538 Jun2012 M003471508SRO Matrix2¿ 2D Soft SR Coils 5mm 471508-SR 11622083,12176098,12229542,12721621, Mar2011 through x8cm 13020445 Sep2012 11800192,11869788,11925606,11940381, 11963592,11996801,12155987,12156601, M003471510SRO Matrix2¿ 2D Soft SR Coils 5mm 471510-SR 12176008,12194708,12314468,12330568, May2011 through x 10cm 12368755,12409141,12514589,12636752, Jun2013 12669963,12670049,12703140,12753166, 12792908,12861687,12981682,13603463 M003471515SRO Matrix2¿ 2D Soft SR Coils 5mm 471515-SR 11384554,11641206,12176118,12182654, Dec2010 through x 15cm 12246986,12649894,13020067 Sep2012 11384857,11748388,11925177,11940389, M003471610SRO Matrix2¿ 2D Soft SR Coils 6mm 471610-SR 11967352,12112307,12155988,12176015, Dec2010 through x 10cm 12330561,12356327,12374220,12847321, Aug2012 12947525,12971457 M003471615SRO Matrix2¿ 2D Soft SR Coils 6mm 471615-SR 11532410,11800196 Feb2011 through x 15cm May2011 1003471620SRO Matrix2¿ 2D Soft SR Coils 6mm 471620-SR 11373732,11634833,12261958,12649895, Dec2010 through x20cm 12792911 Jun2012 M003471710SRO Matrix2¿ 2D Soft SR Coils 7mm 471710-SR 12499178,13108359 Feb2012 through x 10cm Oct2012 M003471715SRO Matrix2¿ 2D Soft SR Coils 7mm 471715-SR 11820280,12229546,12249163 May2011 through x 15cm Nov2011 M003471720SRO Matrix2¿ 2D Soft SR Coils 7mm 471720-SR 11622084,11938494,12246985,12579366 Mar2011 through x20cm Mar2012 M003471820SRO Matrix2¿ 2D Soft SR Coils 8mm 471820-SR 11622082,11766666 Mar2011 through x20cm May2011 M003471830SRO Matrix2¿ 2D Soft SR Coils 8mm 471830-SR 11697466,12229584 Apr2011 through x30cm Nov2011
- 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