Recall Z-1179-2024 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
W.L. Gore & Associates, Inc.
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
| Date | Feb 22, 2024 (initiated Jan 19, 2024) |
| Status | Open, Classified |
| Reason | 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 mea |
| Root cause | Packaging process control |
| Action | On January 19, 2024, the firm notified their distributor via emailed notification. The distributor was instructed to distribute the recall notification to affected end customers. The recall notification, titled URGENT MEDICAL DEVICE RECALL, instructs customers to inspect their inventory for the affected serial numbers and to remove and return any affected product. Accounts with ConMed Corporation consignment inventory should allow their ConMed territory manager to arrange the retrieval of potentially affected consignment inventory. If product has been further distributed, please notify all |
| Quantity | 24 |
| Distribution | US Nationwide distribution in the state of Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis W. L. Gore & Associates, Inc., May 8, 2017 |