W L Gore & Associates, Inc.
Summary
- Total Recalls
- 21
- 510(k) Clearances
- 0
- Inspections
- 9
- Compliance Actions
- 0
Known Names
w. l. gore and associates, w l gore and associates
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0036-2026 | Class II | GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060 | August 26, 2025 |
| Z-2945-2024 | Class II | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: | July 1, 2024 |
| Z-2946-2024 | Class II | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: | July 1, 2024 |
| Z-1048-2023 | Class II | GORE CARDIOFORM Septal Occluder, REF: GSX0030A | December 14, 2022 |
| Z-0136-2023 | Class II | GORE CARDIOFORM ASD Occluder. cardiovascular implant. | September 21, 2022 |
| Z-0077-2022 | Class II | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LA | September 7, 2021 |
| Z-0166-2022 | Class II | REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Leng | September 2, 2021 |
| Z-0164-2022 | Class II | REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Leng | September 2, 2021 |
| Z-0168-2022 | Class II | REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Leng | September 2, 2021 |
| Z-0165-2022 | Class II | REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Leng | September 2, 2021 |
| Z-0172-2022 | Class II | REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Leng | September 2, 2021 |
| Z-0171-2022 | Class II | REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Len | September 2, 2021 |
| Z-0169-2022 | Class II | REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Leng | September 2, 2021 |
| Z-0170-2022 | Class II | REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Len | September 2, 2021 |
| Z-0167-2022 | Class II | REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Leng | September 2, 2021 |
| Z-2292-2021 | Class II | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, | May 12, 2021 |
| Z-2293-2021 | Class II | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, | May 12, 2021 |
| Z-0291-2021 | Class II | GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System | September 9, 2020 |
| Z-0290-2021 | Class II | GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System | September 9, 2020 |
| Z-2052-2020 | Class II | Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for e | December 17, 2019 |