Recall Z-0158-2027 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
W L Gore & Associates, Inc.
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-bas
| Date | Oct 14, 2026 (initiated Sep 3, 2026) |
| Status | Open, Classified |
| Reason | The potential for the devices to be mislabeled with the incorrect length. |
| Root cause | Under Investigation by firm |
| Action | On September 8, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the customer/user: Identify and return any unused devices within the scope of this recall for replacement. Please acknowledge receipt of this letter according to the instructions provided by our distributor, Olympus. This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). Implanting Physicians: If you have implanted one of the potentially mislabeled GORE VIABIL |
| Quantity | 32 |
| Distribution | US Nationwide distribution in the states of GA, RI. |
| 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 |