Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product…
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?
- Generic NameGORE VIABIL Short Wire Biliary Endoprosthesis
- Model/Catalog NumberVSWVH0808
- and VSWVN1006 Product DescriptionThe 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
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published VSWVH0808Model/ — 00733132638772UDI-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 VSWVN1006Model/ — 00733132638864UDI-DI: 00733132638864 — Lot Serial Numbers: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571 - Amount recalled
- 32
Where it was sold
Why it was recalled
The potential for the devices to be mislabeled with the incorrect length.
This product could cause temporary or reversible health problems — stop using it.
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