GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI, NY, DC, SC, CT, NE, IA, WA, AR, NV, WV, AK, UT, ND, KS, CO, ME, MT, NM, SD, PR, WY, RI. OUS: PANAMA, CANADA, CHINA, TAIWAN, GERMANY, SLOVENIA, NORWAY, UNITED KINGDOM, ITALY, SPAIN, FINLAND, NETHERLANDS, SWEDEN, FRANCE, UNITED ARAB EMIRATES, DENMARK, PORTUGAL, AUSTRIA, SWITZERLAND, BELGIUM, TURKIYE, SLOVAK REPUBLIC, CYPRUS, SAUDI ARABIA, SOUTH AFRICA, LUXEMBOURG, FRENCH GUIANA, ANDORRA, IRELAND, NEW CALEDONIA, POLAND, ISRAEL, GREECE, GUADELOUPE, CROATIA, REUNION, BAHRAIN, HUNGARY, JAPAN
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0036-2026