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U.S. Department of Health and Human Services


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Boston Scientific Hemashield VANTAGE Vascular Grafts

Audience: Vascular surgery healthcare professionals and surgical department managers

[UPDATE 09/09/2005] This recall was classified as a Class I recall

[Posted 06/28/2005] Boston Scientific and FDA notified healthcare professionals of a recall of all Hemashield VANTAGE vascular grafts manufactured in the last two years due to the potential for the device, used in peripheral procedures, to fray or tear during suturing and lead to post-operative complications. Boston Scientific is aware of three reported post-operative failures which occurred between three and seven days post-procedure. In all of these cases, the patients were successfully treated by re-suturing the graft or replacing it. Absent symptoms of graft failure, Boston Scientific is recommending that physicians continue routine post-operative clinical evaluation. The signs and symptoms that a graft might be starting to fail include: pain, swelling, bruising, bleeding through incision, rapid pulse or low blood pressure. If a patient experiences any of these symptoms, he or she should contact their physician immediately.

[September 09, 2005 - Recall Notice - FDA]
[June 27, 2005 - Press Release - Boston Scientific]