FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538: Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
- Recall number
- Z-0855-2011
- Recalling firm
- Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
- Product
- Boston Scientific brand Matrix2 Helical 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 M003471204SRO Matrix2¿ Helical Soft SR Coils 471204-SR 11297523,12469527 Oct2010 through 2mm x4cm Feb2012 M003471206SRO Matrix2¿ Helical Soft SR Coils 471206-SR 11422256,11697451,11952856,12361059 Dec2010 through 2mm x6cm Dec2011 M003471208SRO Matrix2¿ Helical Soft SR Coils 471208-SR 11389025,11552556,12514612,13606645 Dec2010 through 2mm x8cm Jun2013
- 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