W L Gore & Associates, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0036-2026)

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.

Class II

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.

REF/UDI-DI: ECH050020J/04993024010758, ECH050020W/00733132635450, ECH050050J/04993024010772, ECH050050W/00733132635474, ECH060010A/00733132622573, ECH060020A/00733132622597, ECH060020J/04993024009967, ECH060020W/00733132634729, ECH060040/00733132605347, ECH060040A/00733132605354, ECH060040W/00733132619719, ECH060050A/00733132626960, ECH060050J/04993024009981, ECH460045A/00733132634811, ECH460045J/04993024010789, ECH470045/00733132626977, ECH470045A/00733132634811. Product with a serial number that includes and falls within the range of 6597081PP001 and 9853822PP024. Instructions for Use MD183888 Revision 4

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

Voluntary: Firm initiated