Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0…
Official notice from a government agency or its published feed.
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: 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-…
Reason: The potential for the devices to be mislabeled with the incorrect length.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of GA, RI.
Reason: The potential for the devices to be mislabeled with the incorrect length.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of GA, RI.
Hazard: The potential for the devices to be mislabeled with the incorrect length.
View the FDA enforcement report ↗ ← All reports