Z-1593-2021Class II

GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers...

Name: Z-1593-2021 GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers...
Creator: W.L. Gore & Associates, Inc.
Published: 2021-04-05
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2021-04-05 / Terminated / root cause: labeling and UDI

FDA source

W.L. Gore & Associates, Inc. began a recall of GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product... on 2021-04-05. FDA classified it as Class II and gives the reason as "The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1593-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-05
Posted: 2021-05-14
Terminated: 2024-01-16
Recalling firm: W. L. Gore & Associates, Inc.
Product: GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.
Quantity in commerce: 61 devices
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy.
Product codes and lots: Serial Number: 22552467, 22552468, 22552469, 22552470, 22552471, 22552472, 22552473, 22552474, 22552475, 22552476, 22552477, 22552478, 22552479, 22552480, 22552481, 22552482, 22552483, 22552484, 22552756, 22552757, 22552758, 22552759, 22552760, 22552761, 22552762, 22552763, 22552764, 22552765, 22552766, 22552767, 22552768, 22552769, 22552770, 22552771, 22552772, 22552773, 22552774, 22552775, 22552776, 22552777, 22552778, 22552779, 22552780, 22552781, 22552782, 22613929, 22613930, 22613931

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1593-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1593-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-14

Product code FGE

K081184Class IIGore Viabil Bililary EndoprosthesisW.L. Gore & Associates, Inc. Medical Products Div. / cleared 2008-07-22

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)