Recall Z-1459-05 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Boston Scientific Corporation
Hemashield Vantage Vascular Graft. Vascular graft prosthesis.
| Date | Sep 28, 2005 (initiated Jun 27, 2005) |
| Status | Terminated |
| Reason | During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon. |
| Root cause | Other |
| Action | Recall notifications were sent out to all customers on 6/27/2005. Enclosed within the recall notification letters are Dear Doctor Letters with directions to the customers to supplyh a copy of it to each physician who has implanted the Hemashield Vantage Vascular Graft. |
| Quantity | 3487 devices |
| Distribution | The devices were distributed to 375 customers in the US, Argentina, Australia, Belgium, China, Colombia, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Italy, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Sweden, Singapore and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961847 | HEMASHIELD VANTAGE (VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp., Jan 22, 1997 |