FDAFDA recall Z-0158-2027 · Oct 21, 2026
W L Gore & Associates, Inc.: Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis recall
Recall found
Product
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.
Reason for recall
The potential for the devices to be mislabeled with the incorrect length.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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;
- Quantity
- 32
- Distribution
- US Nationwide distribution in the states of GA, RI.
- Recalling firm
- W L Gore & Associates, Inc., Flagstaff, AZ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-03
Source: openFDA enforcement record Z-0158-2027 · search recall number Z-0158-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.