FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538: Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
- Recall number
- Z-0858-2011
- Recalling firm
- Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
- Product
- Boston Scientific brand Matrix2 Firm 2D 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 M003480 1030 Matrix2¿ Firm 2D 10mm X 30cm 4801030 11253687,11766663 Oct2010 through 10mm X 30cm May2011 M0034801230 Matrix2¿ Firm 2D 12mm X 30cm 4801230 11766667,12707248 May2011 through 12mm X 30cm May2012 M0034801430 Matrix2¿ Firm 2D 14mm X 30cm 4801430 11697099 Apr2011 14mm X 30cm M0034801630 Matrix2¿ Firm 20 16mm X 30cm 480163 11426183,11766662 Dec2010 through 16mm X 30cm May2011 M0034801830 Matrix2¿ Firm 20 18mm X 30cm 4801830 11411206 Dec2010 18mm X 30cm M0034802030 Matrix2¿ Firm 20 20mm X 30cm 480203 11777398 May2011 20mm X 30cm M0034805150 Matrix2¿ Firm 20 5mm X 15cm 480515 11777399 May2011 5mm X 15cm M0034806150 Matrix2¿ Firm 20 6mm X 15cm 480615 11757096 Apr2011 6mm X 15cm M0034807200 Matrix2¿ Firm 20 7mm X 20cm 480720 11748387,12365836 Apr2011 through 7mm X20cm Jan2012 M0034808300 Matrix2¿ Firm 20 8mm X 30cm 480830 11297219,11991894,12365835 Oct2010 through 8mm X30cm Jan2012 M0034809300 Matrix2¿ Firm 20 9mm X 30cm 480930 11411626,11622081,12365834 Dec2010 through 9mm X30cm 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