Gore Acuseal Vascular Graft (Gore) – Graft Delamination (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
W L Gore & Associates, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
W L Gore & Associates, Inc. is recalling GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060 due to Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to re. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 wlgore3081@sedgwick.com 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: medcomplaints@wlgore.com Questions can be directed to firm Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026