FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1179-2024
- Recalling firm
- W.L. Gore & Associates, Inc.
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2024-01-19
- Posted
- 2024-02-22
- Terminated
- not on file
- 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 means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
- 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 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.
- Quantity
- 24
- Distribution
- US Nationwide distribution in the state of Georgia.
- Lot, serial or model codes
- (1) UDI-DI 00733132638802, Serial Numbers 27063943, 27063944, 27063949, 27063950, 27063952, 27063953; (2) UDI-DI 00733132638871, Serial Numbers 27063379, 27063380, 27063381, 27063382, 27063383, 27063384, 27063385, 27063386, 27063387, 27063426, 27063427, 27063428
- 510(k) numbers
- ["K170740"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3003910212
- Firm city
- Elkton
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28