CLASS II ONGOING Device recall · Reported 20 Oct 2021 · FDA Enforcement Report

Heparin, Gore Viabahn Vbx, Balloon Expandable Endoprothesis recalled

W L Gore & Associates is recalling Heparin, Gore Viabahn Vbx, Balloon Expandable Endoprothesis. The recall was initiated on 7 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 22753580

Quantity recalled2 units

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-0077-2022
FDA event ID: 88721
Recalling firm: W L Gore & Associates, Flagstaff, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 7 Sep 2021
FDA classified: 8 Oct 2021
Reported: 20 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

7 Sep 2021	Recall initiated by company
8 Oct 2021	Classified by FDA	+31 days
20 Oct 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

Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

Product as listed by the FDA

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

Where it was distributed

International distribution to the countries of Italy & Lebanon.

Questions about this recall

Why was it recalled?

Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

Which lots are affected?

Serial Numbers: 22753580

Where was it sold?

International distribution to the countries of Italy & Lebanon.

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

All 30

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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