FDA-Device2026-10-21Class IIMISBRANDING
Gore VIABIL Short Wire Biliary Endoprosthesis recalled for incorrect length labeling
What this means
Some Gore VIABIL Short Wire Biliary Endoprosthesis devices (models VSWVH0808 and VSWVN1006) may have been labeled with the wrong length. These are small, flexible tubes placed in bile ducts to keep them open. If a doctor uses a device with incorrect length information, it could affect proper placement.
- If you implanted one of these devices, check the lot numbers listed in the recall.
- Contact Gore directly or your facility's medical device coordinator to verify the correct device length and any needed corrective steps.
- Report any placement issues or complications to your healthcare provider and the FDA.
The agency's original wording
Hazard
The potential for the devices to be mislabeled with the incorrect length.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of GA, RI.
Affected count
32
Manufactured in
1505 N 4th St, Flagstaff, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0158-2027Want us to check the next one for you?
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