Z-1179-2024Class II

GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm...

Name: Z-1179-2024 GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm...
Creator: W.L. Gore & Associates, Inc.
Published: 2024-01-19
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2024-01-19 / Open, Classified / root cause: packaging

FDA source

W.L. Gore & Associates, Inc. began a recall of 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... on 2024-01-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1179-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-19
Posted: 2024-02-22
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
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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.
Root cause tag: packaging
FDA 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 in commerce: 24
Distribution: US Nationwide distribution in the state of Georgia.
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1179-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1179-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)