Hemashield Vantage Vascular Graft. Vascular graft prosthesis.
FDA device recall Z-1459-05 · posted 2005-09-28 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSY
- Quantity affected
- 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,
- Date initiated
- 2005-06-27
- Date posted
- 2005-09-28
- Date terminated
- 2006-08-21
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMASHIELD VANTAGE (VASCULAR GRAFT (K961847) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-01-22 |