GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to
FDA device recall Z-2915-2026 · posted 2026-08-07 · Open, Classified
Recall details
- Recalling firm
- W L Gore & Associates, Inc.
- Reason for recall
- 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
- Action taken
- On 05/22/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was sent via email to customers informing them that, 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Customers are instructed to: . Identify and return any unused devices within the scope of this recall for replacement. . Complete and sign the enclosed CUSTOMER RESPONSE / DEVICE RECONCILIATION FORM and return to Ashley.Mitch@Olympus.com within 2 weeks of receipt of this notification. . 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 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. If a listed device has been used, please indicate the used device(s) on the CUSTOMER RESPONSE / DEVICE RECONCILIATION FORM and return to Ashley.Mitch@Olympus.com For questions or further assistance - contact Julie Skaife, Global Product Specialist & Brand Manager at juskaife@wlgore.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FGE
- Quantity affected
- 13 units
- Distribution
- U.S. Nationwide distribution in the states of GA and RI.
- Date initiated
- 2026-05-22
- Date posted
- 2026-08-07
- Location
- Flagstaff, AZ
Monitor recalls programmatically
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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 |