Lower risk Medical device recall · FDA · Published January 19, 2024

W. L. Gore Recalls Short Wire Biliary Endoprosthesis Due to Labeling Error Risk

W. L. Gore recalls specific models of short wire biliary endoprosthesis with potential labeling errors that could lead to extended procedure times, unplanned removal, or infections. Affected units include catalog numbers VSWVH1008 and VSWVN1008 with specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1179-2024Medical device W. L. Gore ›

Lower-risk recall

Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. 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.

Take action

Contact the company

Recalling firmW.L. Gore & Associates, Inc.301 Airport Rd · Elkton, MD 21921-4130

✎ GovInfoNow plain-language explainer

W. L. Gore is recalling certain short wire biliary endoprosthesis models due to a labeling error that may cause the device to be mislabeled as having transmural drainage holes when it doesn't. This could lead to longer surgeries, unplanned device removal, or infections. Patients using these devices should contact the manufacturer for guidance. Read more at govinfonow.com/recall/56295-w-l-gore-recalls-short-wire-biliary-endoprosthesis-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/56295-w-l-gore-recalls-short-wire-biliary-endoprosthesis-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1179-2024

Cite this page

“W. L. Gore Recalls Short Wire Biliary Endoprosthesis Due to Labeling Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56295-w-l-gore-recalls-short-wire-biliary-endoprosthesis-due-to. Based on FDA recall #Z-1179-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1179-2024%22&limit=1).

The FDA announced on Jan. 19, 2024, that W.L. Gore & Associates is recalling GORE VIABIL Short Wire Biliary Endoprosthesis devices due to potential mislabeling of transmural drainage holes. The agency said the hazard includes extended procedure time and secondary procedures.

How to tell if you have it

Brand: W. L. Gore
Product: GORE VIABIL Short Wire Biliary Endoprosthesis
Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; UDI-DI 00733132638802; Serial Numbers 27063943, 27063944, 27063949, 27063950, 27063952, 27063953
Catalog Number VSWVN1008, 10 mm x 8 cm; no holes; UDI-DI 00733132638871; Serial Numbers 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, 27063428
Distribution: US Nationwide distribution in the state of Georgia

The hazard

The FDA said devices without transmural drainage holes may be mislabeled as devices with them, or vice versa. Potential health impacts include extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain.

Context

GovInfoNow's records show W L Gore & Associates, Inc. has 18 other recalls on record since 2017-09-25. Other recent recalls of similar products include W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (2026-05-22), W L Gore Thoracic Branch Endoprosthesis Side Branch Component Recall (2026-05-19), and W L Gore ACUSEAL Vascular Graft Recall (2025-08-26). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03), Boston Scientific FARASTAR Ablation Generator Recall (2026-06-11), and Fresenius Medical Care Bicarby Dialysate Recall (2026-05-07).

How to tell if you have this one

Check for catalog numbers VSWVH1008 (10 mm x 8 cm with holes) or VSWVN1008 (10 mm x 8 cm without holes). Look for specific serial numbers listed in the recall notice.

Brand
W. L. Gore
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to W. L. Gore for guidance on whether your device is affected and next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of Georgia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

Jan 19, 2024Firm started the recall
Feb 22, 2024FDA classified it Class II
Feb 28, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56295-w-l-gore-recalls-short-wire-biliary-endoprosthesis-due-to">W. L. Gore Recalls Short Wire Biliary Endoprosthesis Due to Labeling Error Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1179-2024 (January 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1179-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.