Z-0158-2027

Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006...

Name: Z-0158-2027 Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006...
Creator: W L Gore & Associates, Inc.
Published: 2026-09-03
License: https://open.fda.gov/license/

W L Gore & Associates, Inc. / initiated 2026-09-03 / Open, Classified

FDA source

Recall record

Recall number: Z-0158-2027
Status: Open, Classified
Initiated: 2026-09-03
Posted: 2026-10-14
Recalling firm: W L Gore & Associates, Inc.
Product: 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-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.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The potential for the devices to be mislabeled with the incorrect length.
FDA 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 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 device(s) used when you acknowledge receipt according to the enclosed instruction from our distributor, Olympus
Quantity in commerce: 32
Distribution: US Nationwide distribution in the states of GA, RI.
Product codes and lots: 1. Model/Catalog Number: VSWVH0808; UDI-DI: 00733132638772; Lot Serial Numbers: 30907025, 30907033, 30907034, 30907036, 30907023, 30907024, 30907026, 30907027, 30907028, 30907029 (complaint device), 30907030, 30907031, 30907032 (complaint device), 30907035, 30907037, 30907038; 2. Model/Catalog Number: VSWVN1006; UDI-DI: 00733132638864; Lot Serial Numbers: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571;

Product code FGE

K170740Class IIGORE VIABIL Short Wire Biliary EndoprosthesisW. L. Gore & Associates, Inc. / cleared 2017-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-16. View this recall on fda.gov (opens on fda.gov)