FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538: Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
- Recall number
- Z-0857-2011
- Recalling firm
- Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
- Product
- Boston Scientific brand Matrix 3D Omega Standard 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 M0034751030 Matrix2¿ 3D-Omega Standard 475103 13097570 Oct2012 Coils 1 Omm x 30cm M0034753060 Matrix2¿ 3D-Omega Standard 475306 13204826 Dec2012 Coils 3mm x 6cm M0034754060 Matrix2¿ 3D-Omega Standard 475406 13199749 Dec2012 Coils 4mm x 6cm M0034755080 Matrix2¿ 3D-Omega Standard 475508 13204829 Dec2012 Coils 5mm x 8cm M0034755100 Matrix2¿ 3D-Omega Standard 475510 13097571 Oct2012 Coils 5mm x 10cm
- 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