Skip to content

GORE ACUSEAL Vascular Graft recallZ-0036-2026 · W L Gore & Associates, Inc. · initiated Aug 26, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from W L Gore & Associates, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

On 8/26/2025, correction notices were mailed to Vascular Surgeons and other physicians who were informed of the following: No action is required for patients who currently have the device implanted; however, please be aware of delamination as a potential cause of occlusion should clinical issues arise in the future. Management of patients with suspected or confirmed delamination should be guided by the clinical judgment of the treating physician, with careful consideration of the risks and benefits of each treatment option in the context of the individual circumstance. Instructions for use will be updated to include the following: When performing reinterventions on the GORE ACUSEAL Vascular Graft, avoid the use of oversized balloons. A possible complication which may occur with the use of the GORE ACUSEAL Vascular Graft is delamination. Delamination may result in partial or complete occlusion due to hemodynamically significant stenosis or thrombosis and related serious harms, including additional interventions to resolve. IFUs are available at: https://eifu.goremedical.com/ In addition, customers were asked to do the following: 1) Complete and return the acknowledgement form via email to [email protected] 2) This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). To report an event to firm, email: [email protected] Questions can be directed to firm Customer Service (email: [email protected] or by phone at 800-528-8763

Recall details

Recall number
Z-0036-2026
Status
Open, Classified
Initiated by the company
Aug 26, 2025
Posted by the FDA
Oct 2, 2025
Recalling firm
W L Gore & Associates, Inc.
Quantity
52,306
Product code
DSY
FDA submissions
K233551
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, TAIWAN, GERMANY, SLOVENIA, NORWAY, UNITED KINGDOM, ITALY, SPAIN, FINLAND, NETHERLANDS, SWEDEN, FRANCE, UNITED ARAB EMIRATES, DENMARK, PORTUGAL, AUSTRIA, SWITZERLAND, BELGIUM, TURKIYE, SLOVAK REPUBLIC, CYPRUS, SAUDI ARABIA, SOUTH AFRICA, LUXEMBOURG, FRENCH GUIANA, ANDORRA, IRELAND, NEW CALEDONIA, POLAND, ISRAEL, GREECE, GUADELOUPE, CROATIA, REUNION, BAHRAIN, HUNGARY, JAPAN

Product description

GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.

Code information (models, lots, serial numbers)

REF/UDI-DI: ECH050020J/04993024010758, ECH050020W/00733132635450, ECH050050J/04993024010772, ECH050050W/00733132635474, ECH060010A/00733132622573, ECH060020A/00733132622597, ECH060020J/04993024009967, ECH060020W/00733132634729, ECH060040/00733132605347, ECH060040A/00733132605354, ECH060040W/00733132619719, ECH060050A/00733132626960, ECH060050J/04993024009981, ECH460045A/00733132634811, ECH460045J/04993024010789, ECH470045/00733132626977, ECH470045A/00733132634811. Product with a serial number that includes and falls within the range of 6597081PP001 and 9853822PP024. Instructions for Use MD183888 Revision 4

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page