W L Gore & Associates recalls
10 official recalls and safety alerts involving W L Gore & Associates since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with W L Gore & Associates or the relevant agency.
- 2026-08-19
USW L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain…
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
FDA · DeviceW L Gore & Associates, Inc.U.S. Nationwide distribution in the states of GA and RI.Official notice →- 2026-07-08
- US
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and…
Due to catheter separation
FDA · DeviceW L Gore & Associates, Inc.Worldwide - U.S. Nationwide distribution including in the states and…Official notice → - 2025-10-08
- US
W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…
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…
FDA · DeviceW L Gore & Associates, Inc.US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI,…Official notice → - 2024-09-11
- US
W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A…
Due to packaging defects, sterility assurance and heparin activity may be compromised.
FDA · DeviceW L Gore & Associates, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2024-08-14
- US
W.L. Gore & Associates, Inc. recalls GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.Official notice → - 2024-02-28
- US
W.L. Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2)…
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary…
FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the state of Georgia.Official notice → - 2023-02-08
- US
W L Gore & Associates, Inc. recalls GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could…
FDA · DeviceW L Gore & Associates, Inc.US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA,…Official notice → - 2022-11-02
- US
W L Gore & Associates, Inc. recalls GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Due to manufacturing records (Release Test Results) indicating "Failed".
FDA · DeviceW L Gore & Associates, Inc.Worldwide distribution - U.S. Nationwide distribution including in the states…Official notice → - 2021-11-03
- US
W L Gore & Associates, Inc. recalls REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr,…
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
FDA · DeviceW L Gore & Associates, Inc.US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD,…Official notice → - 2021-10-20
- US
W L Gore & Associates, Inc. recalls Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal…
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.
FDA · DeviceW L Gore & Associates, Inc.International distribution to the countries of Italy & Lebanon.Official notice →