Reported Aug 19, 2026 · Ongoing · Updated Sep 16, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to…
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?
- 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.
- Lot codes and dates
- Incorrect Catalogue Number/UDI
VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888VSWVN1010 / 00733132638888Lot Serial No. 30965053309650543096505530965056309650573096505830965059309650603096506130965062309650633096506430965065
- Incorrect Catalogue Number/UDI
- Amount recalled
- 13 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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