W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall: Incorrect Labeling Risk
W L Gore recalls GORE VIABIL Short Wire Biliary Endoprosthesis Model VSWVN1006 due to incorrect labeling that could lead to improper medical use. Affected units have specific serial numbers and catalog codes.
Recall notice
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
What happened, in plain English
W L Gore is recalling a specific biliary stent model because it was incorrectly labeled. This could lead to improper medical use if the device is not used as intended. Patients should check if their device matches the described model and serial numbers. Read more at govinfonow.com/recall/459641-w-l-gore-gore-viabil-short-wire-biliary-endoprosthesis-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/459641-w-l-gore-gore-viabil-short-wire-biliary-endoprosthesis-recall · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2915-2026
Cite this page
“W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459641-w-l-gore-gore-viabil-short-wire-biliary-endoprosthesis-recall. Based on FDA recall #Z-2915-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2915-2026%22&limit=1).
Why it’s dangerous
The device was labeled incorrectly as a 10 mm diameter x 10 cm length without drainage holes when it is actually a 10 mm diameter x 7 cm device with drainage holes. This mismatch could cause improper placement or function during medical procedures, potentially leading to complications.
Who’s affected
Patients who have the GORE VIABIL Short Wire Biliary Endoprosthesis Model VSWVN1006 with the listed serial numbers are most at risk. Medical professionals using this device for bile duct procedures may also be affected.
How to tell if you have this one
Check for the model number VSWVN1006 on the device packaging or label. Look for the specific serial numbers listed: 30970948 through 30970960. The incorrect labeling affects the device's intended use in bile duct procedures.
- Brand
W L Gore- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
U.S. Nationwide distribution in the states of GA and RI.
| Recall number | Product, codes & lots |
|---|---|
| Z-2914-2026 | GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.; Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065. |
| Z-2915-2026 | GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.; Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796; Lot Serial No. 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960. |
What to do — step by step
Check Device Label
Look for the model number VSWVN1006 and serial numbers 30970948 to 30970960 on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “U.S. Nationwide distribution in the states of GA and RI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Rhode Island.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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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-2915-2026 (May 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2915-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 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.