Z-2915-2026Class II

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis...

Name: Z-2915-2026 GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis...
Creator: W L Gore & Associates, Inc.
Published: 2026-05-22
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2026-05-22 / Open, Classified / root cause: manufacturing process

FDA source

W L Gore & Associates, Inc. began a recall of GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common... on 2026-05-22. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2915-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-22
Posted: 2026-08-07
Recalling firm: W. L. Gore & Associates, Inc.
Product: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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 [email protected] For questions or further assistance - contact Julie Skaife, Global Product Specialist & Brand Manager at [email protected].
Quantity in commerce: 13 units
Distribution: U.S. Nationwide distribution in the states of GA and RI.
Product codes and lots: Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796; Lot Serial No. 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2915-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2914-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2915-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07

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)