Reported Oct 8, 2025 · Ongoing
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J,…
W L Gore & Associates, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: W L Gore & Associates, Inc. · 1505 N 4th St · Flagstaff, AZ · 86004-5867
Is this the product you have?
- GORE ACUSEAL Vascular Graft
- REF
ECH050020JECH050020WECH050050JECH050050WECH060010AECH060020AECH060020JECH060020WECH060040ECH060040AECH060040WECH060050AECH060050JECH460045AECH460045JECH470045ECH470045Aused with Instructions for Use
- Lot codes and dates
- REF/UDI-DIECH050020J/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
- Amount recalled
- 52,306
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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