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W L Gore & Associates, Inc. FDA Recalls
24 recalls on file across devices, 0 of them Class I and 23 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to Class IIMay 22, 202610 mm diameter x 7 cm with transmural drainage holes (VSWVH1 |
| GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to Class IIMay 22, 202610 mm diameter x 7 cm with transmural drainage holes (VSWVH1 |
| GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes PuClass IIMay 19, 2026Due to catheter separation |
| GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECClass IIAug 26, 2025Reports of vascular graft delamination, which may lead to re |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;Class IIJul 3, 2024Devices were labeled with an expiration date of four years a |
| Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXClass IIJul 1, 2024Due to packaging defects, sterility assurance and heparin ac |
| Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXClass IIJul 1, 2024Due to packaging defects, sterility assurance and heparin ac |
| GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with hoClass IIJan 19, 2024Devices without transmural drainage holes may be mislabeled |
| GORE CARDIOFORM Septal Occluder, REF: GSX0030AClass IIDec 14, 2022Septal Occluders released with incomplete quality test docum |
| GORE CARDIOFORM ASD Occluder. cardiovascular implant.Class IISep 21, 2022Due to manufacturing records (Release Test Results) indicati |
| Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBClass IISep 7, 2021Incorrect labeling, specifically, expandable endoprosthesis |
| REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery PClass IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery PClass IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery PClass IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery PClass IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Class IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery PClass IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Class IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery PClass IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery PClass IISep 2, 2021Septal Occluders contain the incorrect expiration date. Prod |
| Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire CompatClass IIJul 12, 2021Complaints received concerning Balloon Catheter leakage from |
| Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the Class IIMay 12, 2021Vascular Grafts containing an inner diameter of 6 mm may be |
| Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the Class IIMay 12, 2021Vascular Grafts containing an inner diameter of 6 mm may be |
| GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH10Class IIApr 5, 2021The Gore post market surveillance team received a complaint |