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Boston Scientific Announces Worldwide Recall of Hemashield® Vantage™ Peripheral Vascular Grafts

Jun 27, 2005 | www.fda.gov

Boston Scientific Corporation (NYSE: BSX) today announced that it is voluntarily recalling worldwide all Hemashield ® VANTAGE™ Vascular Grafts, which are used in peripheral procedures. No other Hemashield ® products are affected by this recall. The Company is recalling all Hemashield VANTAGE Vascular Grafts manufactured in the last two years due to the potential of the device to fray or tear during suturing and the possibility that it could lead to post-operative complications.

The Company 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. The Company is working with the U. S. Food and Drug Administration and is notifying officials in other countries.

The recalled devices include all Hemashield VANTAGE Vascular Grafts. The Company initiated the recall after a review of complaint records and analysis of product revealed the potential problem. The total number of devices shipped but not yet implanted is estimated to be 500. The Company ships approximately 2,180 Hemashield VANTAGE Vascular Grafts per year.

The products were distributed to hospitals worldwide. Boston Scientific is notifying hospitals through detailed Recall Packages, including instructions on how to return recalled product, as well as physician letters. All unimplanted product is to be returned to Boston Scientific.

Physicians with questions may contact the Company at 1-888-272-1001.

Absent symptoms of graft failure, Boston Scientific is recommending that physicians continue routine post-operative clinical evaluation. The signs and symptoms that a Hemashield VANTAGE Vascular 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.

Hemashield VANTAGE Vascular Grafts generated revenues of $1.2 million in 2004.


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