Lower risk Medical device recall · FDA · Published September 7, 2021

W L Gore Heparin Stent Recall: Incorrect Labeling Risk

W L Gore recalls specific heparin stents due to incorrect labeling that may contain a larger size than listed. Affected units have serial numbers starting with 22753580.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0077-2022Medical device W L Gore ›

Lower-risk 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.

Take action

Contact the company

Recalling firmW L Gore & Associates, Inc.3750 W Kiltie Ln · Flagstaff, AZ 86005-8712

✎ GovInfoNow plain-language explainer

W L Gore is recalling a specific type of heparin stent that may have incorrect labeling. This could mean the stent is larger than listed, which might cause complications during medical procedures. Read more at govinfonow.com/recall/61829-w-l-gore-heparin-stent-recall-incorrect-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61829-w-l-gore-heparin-stent-recall-incorrect-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0077-2022

Cite this page

“W L Gore Heparin Stent Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61829-w-l-gore-heparin-stent-recall-incorrect-labeling-risk. Based on FDA recall #Z-0077-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0077-2022%22&limit=1).

The FDA announced on 2021-09-07 that W L Gore & Associates, Inc. voluntarily recalled Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS due to incorrect labeling risks. The device may contain a different size than labeled.

How to tell if you have it

Brand: W L Gore
Product: Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS
REF: BXAL085902E
Size: 8 MM X 59 MM 8 Fr
Serial Numbers: 22753580
Quantity: 2 units

The hazard

The expandable endoprosthesis is labeled as 8 mm x 59mm x 135 cm but may contain a 9mm x 29 mm x 135 cm device. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show W L Gore & Associates, Inc. has 18 other recalls on record since 2017-09-25. Other recent recalls of similar products include Bard Ureteral Stent Kit Recall (2025-11-06) and BD InLay Optima Ureteral Stent Kit (2025-11-06).

How to tell if you have this one

Check for serial numbers starting with 22753580 on the stent packaging. The product is labeled as Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON.

Brand
W L Gore
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Stent Label
Look for the serial number starting with 22753580 on the stent packaging.

How this recall unfolded

Recall timeline

FDA published this recall 43 days after the firm started it.

Sep 7, 2021Firm started the recall
Oct 8, 2021FDA classified it Class II
Oct 20, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury?

The recall is for potential size mismatch, which could lead to complications but does not indicate a risk of serious injury in normal use.

Similar recalls

Latest medical device recalls

Keep exploring

More W L Gore recalls

Link to this recall

<a href="https://govinfonow.com/recall/61829-w-l-gore-heparin-stent-recall-incorrect-labeling-risk">W L Gore Heparin Stent Recall: Incorrect Labeling Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0077-2022 (September 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0077-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.