Recall Z-0036-2026— W L Gore & Associates, Inc.

Name: FDA recall Z-0036-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-26

Class II · Ongoing

Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2025-08-26. It names one FDA 510(k) clearance: K233551. 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.. Reason: 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..

Recalling firm: W L Gore & Associates, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-26
Firm location: Flagstaff, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K233551 — GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.·cleared 2023-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.