Terminated

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.

FDA Recall Z-0857-2011 · Posted 2011-01-05

Recalling FirmBoston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538

Recall StatusTerminated

Product CodeHGC

Date Initiated2010-10-19

Date Terminated2012-01-27

Product Quantity77,364 total units

Reason for Recall

The product appears to have premature degradation of the PGLA coating on the Matrix Coil.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031168MATRIX STRETCH RESISTANT DETACHABLE COILBoston Scientific, Target · 2003-05-14 K012985MATRIX DETACHABLE COILSBoston Scientific, Target · 2002-01-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.