Recall Z-0668-2007 ยท HCG Device, Neurovascular Embolization
Boston Scientific Target
Matrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog Number: 494203, UPN: M0034942030, Distributed and Manufactured by Boston Scientific Corporation, Neurovascular Division, Fremont, CA
| Date | Mar 29, 2007 (initiated Feb 7, 2007) |
| Status | Terminated |
| Reason | The product may be missing the temperature indicator label on the inner pouch. |
| Root cause | Other |
| Action | The firm initiated the recall on 02/07/2007, and initially notified consignees via letter. |
| Quantity | 57 units |
| Distribution | Worldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050700 | MATRIX STRETCH RESISTANT (SR) COILS Boston Scientific Corp, Apr 15, 2005 |