INDICATIONS FOR USE The ProCol® Vascular Bioprosthesis is intended for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft. CONTRAINDICATIONS None known. WARNINGS The device should not be used when host vessels are of insufficient quality to avoid anastomotic aneurysms. Do not flush or implant the bioprosthesis opposite the direction of flow. Do not use bioprostheses from containers found to be damaged, leaking, without adequate storage solution or with broken or missing seals. PRECAUTIONS Read instructions carefully before use. The device should not be used unless there is adequate runoff. The safety and effectiveness of the ProCol® Vascular Bioprosthesis in de novo patients have not been established. POTENTIAL ADVERSE EVENTS The following adverse events may be associated with the use of a vascular access graft: needle stick damage resulting in bleeding and/or pseudoaneurysms, hemorrhage, anastomotic aneurysms, steal, patient sensitivity to device materials, graft dilatation, thrombosis/occlusion of graft, infection, swelling of affected limb, embolic events, stenosis, slow wound healing, failure to achieve access, events associated with an invasive surgical procedure. Caution: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).