Vascular grafts recalled after delamination reports prompt instructions for use update
W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.
- 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.
- Category
- Medical Device
- Distribution
- 51 states