PlainRecalls

W L Gore & Associates, Inc.

18 recalls on record · Latest: Aug 14, 2024

FDA Devices Moderate Aug 14, 2024

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

FDA Devices Moderate Feb 28, 2024

GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number …

FDA Devices Moderate Feb 8, 2023

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx…

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx…

FDA Devices Moderate Oct 20, 2021

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 m…

FDA Devices Moderate Sep 1, 2021

Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, C…

FDA Devices Moderate Aug 25, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: …

FDA Devices Moderate Aug 25, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: …

FDA Devices Moderate May 26, 2021

GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 -…

FDA Devices Moderate Nov 4, 2020

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

FDA Devices Moderate Feb 12, 2020

GORE¿ EXCLUDER¿ AAA Endoprosthesis

FDA Devices Moderate Feb 12, 2020

GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

FDA Devices Moderate Nov 1, 2017

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the d…