FDA issues Safety Alert for Baxter’s Vascu-Guard patch

Editor's Note

The Food and Drug Administration (FDA) on September 1 issued a Safety Alert for Baxter International’s (Deerfield, Illinois) Vascu-Guard Peripheral Vascular Patch.

The FDA has received multiple adverse event reports associated with use of the Vascu-Guard patch during carotid endarterectomy, including intraoperative or postoperative bleeding and hematomas as well as three patient deaths.

Reports of intraoperative or postoperative bleeding and hematomas, some of which required additional intervention, and three patient deaths potentially related to this issue that occurred shortly after carotid endarterectomy surgery.