Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and
FDA device recall Z-0857-2011 · posted 2011-01-05 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
- Reason for recall
- The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Action taken
- 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
- Status
- Terminated
- Product code
- HGC
- Quantity affected
- 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, Gre
- Date initiated
- 2010-10-19
- Date posted
- 2011-01-05
- Date terminated
- 2012-01-27
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MATRIX STRETCH RESISTANT DETACHABLE COIL (K031168) | Boston Scientific, Target | 2003-05-14 |
| MATRIX DETACHABLE COILS (K012985) | Boston Scientific, Target | 2002-01-31 |