FDAnews
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BOSTON SCIENTIFIC RECALLS HEMASHIELD GRAFTS

June 28, 2005

Devicemaker Boston Scientific initiated a worldwide voluntarily recall of all Hemashield Vantage Vascular Grafts that were made in the last two years because they may fray or tear during suturing, and could cause postoperative complications.

Problems with the grafts, which are used in peripheral heart procedures, have been reported in three postoperative 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.

Boston Scientific initiated the recall after a review of complaint records and product analysis revealed the potential problem. The total number of devices shipped but not yet implanted is estimated to be 500. The company recommends that physicians continue routine postoperative clinical evaluation. No other Hemashield products are affected by this recall.