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.

On 8/26/2025, correction notices were mailed to Vascular Surgeons and other physicians who were informed of the following: No action is required for patients who currently have the device implanted; however, please be aware of delamination as a potential cause of occlusion should clinical issues arise in the future. Management of patients with suspected or confirmed delamination should be guided by the clinical judgment of the treating physician, with careful consideration of the risks and benefits of each treatment option in the context of the individual circumstance. Instructions for use will be updated to include the following: When performing reinterventions on the GORE ACUSEAL Vascular Graft, avoid the use of oversized balloons. A possible complication which may occur with the use of the GORE ACUSEAL Vascular Graft is delamination. Delamination may result in partial or complete occlusion due to hemodynamically significant stenosis or thrombosis and related serious harms, including additional interventions to resolve. IFUs are available at: https://eifu.goremedical.com/ In addition, customers were asked to do the following: 1) Complete and return the acknowledgement form via email to [email protected] 2) This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). To report an event to firm, email: [email protected] Questions can be directed to firm Customer Service (email: [email protected] or by phone at 800-528-8763