Device recall
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
- Recall number
- Z-0158-2027
- Event id
- 99873
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- W L Gore & Associates, Inc.
- Report date
- Oct 21, 2026
- Posted
- Oct 14, 2026
- Initiated
- Sep 3, 2026
- Center classification date
- Oct 14, 2026
- Product code
- FGE
- Device type
- Stents, Drains And Dilators For The Biliary Ducts
- Reason
- The potential for the devices to be mislabeled with the incorrect length.
- Root cause
- Under Investigation by firm
- Quantity
- 32
- Code info
- 1. Model/Catalog Number: VSWVH0808; UDI-DI: 00733132638772; Lot Serial Numbers: 30907025, 30907033, 30907034, 30907036, 30907023, 30907024, 30907026, 30907027, 30907028, 30907029 (complaint device), 30907030, 30907031, 30907032 (complaint device), 30907035, 30907037, 30907038; 2. Model/Catalog Number: VSWVN1006; UDI-DI: 00733132638864; Lot Serial Numbers: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571;
- Distribution
- US Nationwide distribution in the states of GA, RI.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K170740
- Location
- Flagstaff, AZ, United States