W L Gore & Associates, Inc.: 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.

Recall number

Z-0036-2026

Recalling firm

W L Gore & Associates, Inc.

Product

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.

Status

Open, Classified

Initiated

2025-08-26

Posted

2025-10-02

Terminated

not on file

Reason

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.

Root cause

Unknown/Undetermined by firm

Action

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 wlgore3081@sedgwick.com 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: medcomplaints@wlgore.com Questions can be directed to firm Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763

Quantity

52,306

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

Lot, serial or model codes

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

510(k) numbers

["K233551"]

PMA numbers

not on file

Product code

DSY

Firm FEI

2017233

Firm city

Flagstaff

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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