Lower risk Medical device recall · FDA · Published August 26, 2025

W L Gore ACUSEAL Vascular Graft Recall: Risk of Delamination Leading to Bleeding

W L Gore recalls ACUSEAL Vascular Graft models ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, and others due to reported delamination causing bleeding, bruising, and cannulation difficulties.

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

🇺🇸 FDA recall #Z-0036-2026Medical device W L Gore ›

Lower-risk recall

Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.

Take action

Contact the company

Recalling firmW L Gore & Associates, Inc.1505 N 4th St · Flagstaff, AZ 86004-5867

✎ GovInfoNow plain-language explainer

W L Gore is recalling ACUSEAL Vascular Grafts with specific model numbers because they may delaminate, leading to reduced blood flow, bleeding, bruising, or complications during medical procedures. This recall is important for patients and healthcare providers using these grafts to prevent potential harm. Read more at govinfonow.com/recall/51547-w-l-gore-acuseal-vascular-graft-recall-risk-of-delamination.

Source Summary by GovInfoNow · govinfonow.com/recall/51547-w-l-gore-acuseal-vascular-graft-recall-risk-of-delamination · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0036-2026

Cite this page

“W L Gore ACUSEAL Vascular Graft Recall: Risk of Delamination Leading to Bleeding.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51547-w-l-gore-acuseal-vascular-graft-recall-risk-of-delamination. Based on FDA recall #Z-0036-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0036-2026%22&limit=1).

The FDA announced on August 26, 2025, that W L Gore & Associates, Inc. is recalling GORE ACUSEAL Vascular Grafts due to reports of vascular graft delamination. The agency stated the hazard may lead to reduced access flow and other complications.

How to tell if you have it

Brand: W L Gore
Product: GORE ACUSEAL Vascular Graft
REF codes: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A
Serial number range: 6597081PP001 to 9853822PP024
Instructions for Use: MD183888 Revision 4

The hazard

According to the FDA, reports indicate vascular graft delamination which may lead to reduced access flow, cannulation difficulties, bleeding or bruising, and harms related to reintervention procedures. The agency noted that Instructions for Use will be updated to modify existing warnings regarding these risks.

Context

GovInfoNow's records show W L Gore & Associates, Inc. has 18 other recalls on record since September 25, 2017. Other recent recalls of similar products include W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (May 22, 2026), W L Gore Thoracic Branch Endoprosthesis Side Branch Component Recall (May 19, 2026), and W. L. Gore GORE SEAMGUARD Staple Line Reinforcement Recall (July 3, 2024). Other recent recalls of similar products include LeMait Artegraft Vascular Graft Recall Due to Labeling Mix-Up (February 10, 2026), Medline Surgical Gowns Recall (January 28, 2026), and Intervascular Cardioroot Vascular Grafts May Fail Water Permeability Test (August 12, 2026).

How to tell if you have this one

Check the product's model number on the packaging or label. The recalled grafts have model numbers starting with ECH050020, ECH050050, ECH060010, ECH060020, ECH060040, ECH060050, or ECH460045. The serial number falls between 6597081PP001 and 9853822PP024.

Brand
W L Gore
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Model
Look for the model number on the graft packaging or label to confirm if it is in the recalled list.
Review Instructions for Use
Ensure you have the latest version of the Instructions for Use (MD183888 Revision 4) to follow updated safety guidelines.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI, NY, DC, SC, CT, NE, IA, WA, AR, NV, WV, AK, UT, ND, KS, CO, ME, MT, NM, SD, PR, WY, RI. OUS: PANAMA, CANADA, CHINA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

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

Aug 26, 2025Firm started the recall
Oct 2, 2025FDA classified it Class II
Oct 8, 2025Published 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

Do I need to stop using this product?

No, the recall does not require stopping use immediately. However, you should check if your product is affected and follow the updated Instructions for Use.

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Link to this recall

<a href="https://govinfonow.com/recall/51547-w-l-gore-acuseal-vascular-graft-recall-risk-of-delamination">W L Gore ACUSEAL Vascular Graft Recall: Risk of Delamination Leading to Bleeding (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-0036-2026 (August 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0036-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.