Recall Z-0855-2011 ยท HGC Clamp, Uterine
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.
| Date | Jan 5, 2011 (initiated Oct 19, 2010) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |