GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes
FDA device recall Z-1179-2024 · posted 2024-02-22 · Open, Classified
Recall details
- Recalling firm
- W.L. Gore & Associates, Inc.
- Reason for recall
- 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.
- Action taken
- 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 downstream accounts. Implanting Physicians: If you have implanted one of the potentially mislabeled GORE VIABIL Short Wire Biliary Endoprosthesis devices, please be mindful of the potential health outcomes and plan to take the needed measures that could minimize any potential health hazards associated with this mislabeling.
- Root cause
- Packaging process control
- Status
- Open, Classified
- Product code
- FGE
- Quantity affected
- 24
- Distribution
- US Nationwide distribution in the state of Georgia.
- Date initiated
- 2024-01-19
- Date posted
- 2024-02-22
- Location
- Elkton, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GORE VIABIL Short Wire Biliary Endoprosthesis (K170740) | W. L. Gore & Associates, Inc. | 2017-05-08 |