Reported Feb 28, 2024 · Ongoing
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with…
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. · 301 Airport Rd · Elkton, MD · 21921-4130
Is this the product you have?
- GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
- Lot codes and dates
(1) UDI-DI 00733132638802Serial Numbers 270639432706394427063949270639502706395227063953(2) UDI-DI 00733132638871Serial Numbers 270633792706338027063381270633822706338327063384270633852706338627063387270634262706342727063428
- Amount recalled
- 24
Where it was sold
- Nationwide
- GA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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