Z-0857-2011

Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial...

Name: Z-0857-2011 Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial...
Creator: Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
Published: 2010-10-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-10-19 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 began a recall of Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations... on 2010-10-19. The reason FDA records is "The product appears to have premature degradation of the PGLA coating on the Matrix Coil". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0857-2011
Status: Terminated
Initiated: 2010-10-19
Posted: 2011-01-05
Terminated: 2012-01-27
Recalling firm: Boston Scientific Corporation
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.
Product code: HGC Clamp, Uterine
Reason for recall: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code HGC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)