GORE VIABIL Short Wire Biliary Endoprosthesis recall
W L Gore & Associates, Inc. recalled GORE VIABIL Short Wire Biliary Endoprosthesis on August 19, 2026 because of 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). It was sold nationwide.
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).
What's recalled
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.
Quantity: 13 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- W L Gore & Associates, Inc., Flagstaff, AZ
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
U.S. Nationwide distribution in the states of GA and RI. - Status
- Ongoing
- Recall number
- Z-2915-2026
- Source
- U.S. Food and Drug Administration
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