| Date Recall Initiated: |
June 27, 2005 |
|---|---|
| Product: |
Hemashield® VANTAGE™ Vascular Grafts |
| Use: |
The Hemashield VANTAGE vascular graft is intended for use in surgical treatment of peripheral vascular disease. It is most often used to replace or bypass part of an artery in the leg. |
| Recalling Firm: |
Boston Scientific Corporation 1 Boston Scientific Place Natick, Massachusetts, 01760-1536 |
| Reason for Recall: |
The device fabric may fray and tear at the suture line between the graft and the patient's artery. If this happens postoperatively, the problem can result in blood loss leading to serious injury or death. |
Public Contact: |
Jennifer Bolton Manager, Regulatory Affairs, Vascular Surgery Boston Scientific Corporation 2 Scimed Place Maple Grove, Minnesota, 55311 763-494-1163 |
| FDA District: |
New Jersey |
| Advice to Users: |
Any recalled grafts remaining in the hospital inventory should
not be used.
The three known postoperative tears occurred within a week of surgery. Boston Scientific believes that the risk of graft tears becomes less when the graft heals into the surrounding body tissue. In their recall notice, Boston Scientific did not recommend removal of these grafts from patients unless there are graft-related problems that need to be corrected. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. |
Physicians and patients who have questions about the recall may contact Boston Scientific at 1-888-272-1001. A copy of the company’s press release regarding this recall can be found at: http://www.fda.gov/oc/po/firmrecalls/bostonsci06_05.html. |
Updated September 9, 2005
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