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GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm

FDA Recall
Terminated ·W L Gore & Assoc, Inc.·Product code MIH·April 28, 2006

REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US

FDA Recall
Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032

FDA Recall
Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375

FDA Recall
Open, Classified ·W L Gore & Associates, Inc.·Product code DSY·May 12, 2021

Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J

FDA Recall
Open, Classified ·W L Gore & Associates, Inc.·Product code PRL·July 1, 2024

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

FDA Recall
Terminated ·W L Gore & Associates, Inc.·Product code MIH·September 25, 2017

REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

FDA Recall
Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

FDA Recall
Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·December 14, 2022

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

FDA Recall
Open, Classified ·W L Gore & Associates, Inc.·Product code MIH·September 9, 2020

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

FDA Recall
Open, Classified ·W L Gore & Associates, Inc.·Product code MIH·September 9, 2020

REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

FDA Enforcement
Class II ·Terminated·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·March 7, 2018

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.

FDA Enforcement
Class II ·Ongoing·W L Gore & Associates, Inc.·October 8, 2025

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

FDA Enforcement
Class II ·Terminated·W L Gore & Associates, Inc.·November 1, 2017

GORE¿ EXCLUDER¿ AAA Endoprosthesis

FDA Enforcement
Class II ·Terminated·W. L. Gore & Associates Inc.·February 12, 2020

GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

FDA Enforcement
Class II ·Terminated·W. L. Gore & Associates Inc.·February 12, 2020

Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.

FDA Enforcement
Class II ·Terminated·W L Gore & Associates, Inc.·May 27, 2020

Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.

FDA Enforcement
Class II ·Terminated·W. L. Gore & Associates Inc.·May 20, 2020

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

FDA Enforcement
Class II ·Ongoing·W L Gore & Associates, Inc.·November 4, 2020

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

FDA Enforcement
Class II ·Ongoing·W L Gore & Associates, Inc.·November 4, 2020

REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US

FDA Enforcement
Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021