CLASS II Device recall · Reported 26 May 2021 · FDA Enforcement Report

Gore Vibil Biliary Endoprosthesis: stents, drains recalled

W.L. Gore & Associates is recalling Gore Vibil Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts, distributed nationwide in the US. The recall was initiated on 5 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled61 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1593-2021
FDA event ID: 87699
Recalling firm: W.L. Gore & Associates, Elkton, MD
Classification: Class II
Status: Terminated
Recall initiated: 5 Apr 2021
FDA classified: 14 May 2021
Reported: 26 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

5 Apr 2021	Recall initiated by company
14 May 2021	Classified by FDA	+39 days
26 May 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arizona California Colorado Connecticut Florida Georgia Hawaii Illinois Kansas Maryland Minnesota Nebraska New York Oklahoma Rhode Island Texas Virginia

Questions about this recall

Why was it recalled?

The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from W.L. Gore & Associates

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Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
8 Jul 2026Device	CLASS II	GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled	W L Gore & Associates	Other	Nationwide
8 Oct 2025Device	CLASS II	Gore Acuseal Vascular Graft recalled by W L Gore & Associates	W L Gore & Associates	Packaging Defects	51 states
11 Sep 2024Device	CLASS II	Heparin, Gore Viabahn VBX, Balloon Expandable recalled	W L Gore & Associates	Sterility	Nationwide

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