GORE ACUSEAL Vascular Graft — Class II medical device recall Z-0036-2026
Ongoing recall by W L Gore & Associates, Inc., reported 2025-10-08, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleed
| Recall number | Z-0036-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W L Gore & Associates, Inc., Flagstaff, AZ, United States |
| Recall initiated | 2025-08-26 |
| Classified | 2025-10-02 |
| Reported by FDA | 2025-10-08 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AE, AT, BE, BH, CA, CH, CN, CY, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, LU, NL, NO, PA, PL, PT, SA, SE, SI, TW, ZA |
| Quantity | 52,306 |
| UPC / GTIN / UDI-DI | 00733132605347, 00733132605354, 00733132619719, 00733132622573, 00733132622597, 00733132626960, 00733132626977, 00733132634729, 00733132634811, 00733132635450, 00733132635474, 04993024009967, 04993024009981, 04993024010758, 04993024010772, 04993024010789 |
| Model numbers | ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A |
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.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0036-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.