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.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
This press release contains forward-looking statements. The Company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with the regulatory process, litigation, competitive product offerings and other factors described in the Company