Official recall notice
FDA DeviceClass IINotable
FDA Recall: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endopro
- Recall date
- 2026-08-19
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Recommended action
What to do
13 units
Product description
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).