W. L. Gore & Associates, Inc.
W. L. Gore & Associates, Inc. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2025, with 29 FDA device recalls on record.
Top product codes for W. L. Gore & Associates, Inc.
FDA recalls by W. L. Gore & Associates, Inc.
10 most recent of 29- Z-2672-2026 — GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE¿ TAG¿ Conformable Thoracic Endoprosthesis to accommodate the intended treatment site.
- Z-0036-2026 — 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.
- Z-2513-2024 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
- Z-2946-2024 — Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
- Z-2945-2024 — 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
- Z-1179-2024 — GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
- Z-1048-2023 — GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Z-0136-2023 — GORE CARDIOFORM ASD Occluder. cardiovascular implant.
- Z-0077-2022 — Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
- Z-0171-2022 — 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by W. L. Gore & Associates, Inc.
1–100 of 163- K250410 — GORE® Tri-Lobe Balloon Catheter
- K240083 — GORE® PROPATEN® Vascular Graft
- K232312 — GORE® PROPATEN® Vascular Graft
- K233551 — GORE® ACUSEAL Vascular Graft
- K231505 — GORE® ACUSEAL Vascular Graft
- K191773 — GORE BIO-A Tissue Reinforcement
- K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
- K173333 — GORE ENFORM Biomaterial
- K163576 — GORE SYNECOR Preperitoneal Biomaterial
- K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis
- K163217 — GORE BIO-A Tissue Reinforcement
- K160254 — GORE DrySeal Flex Introducer Sheath
- K152609 — GORE SYNECOR Biomaterial
- K150551 — GORE SEAMGUARD Reinforcement
- K132397 — GORE BIO-A WOUND MATRIX
- K131658 — GORE SEAMGUARD REINFORCEMENT
- K130215 — GORE ACUSEAL VASCULAR GRAFT
- K123156 — GORE FLOW REVERSAL SYSTEM MODEL GFRS073
- K121234 — GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
- K120428 — GORE DRYSEAL SHEATH
- K103500 — GORE EMBOLIC FILTER
- K093791 — GORE DRYSEAL SHEATH
- K083266 — GORE BIO-A FISTULA PLUG
- K083300 — GORE FLOW REVERSAL SYSTEM
- K081799 — GORE TRI-LOBE BALLOON CATHETER
- K082356 — GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
- K081069 — GORE INFINIT MESH
- K070770 — GORE BALLOON SHEATH
- K070644 — GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
- K063435 — GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
- K062161 — GORE PROPATEN VASCULAR GRAFT
- K061727 — GORE PRECLUDE VESSEL GUARD
- K053200 — GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K051267 — GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
- K043056 — GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K043081 — GORE POLYPROPYLENE HERNIA MESH
- K041423 — VIABIL BILIARY ENDOPROSTHESIS
- K033670 — GORE TRI-LOBE BALLOON CATHETER
- K033671 — GORE BIOABSORBABLE MESH
- K032865 — GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K032168 — GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
- K032073 — GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
- K031089 — GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
- K030782 — SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K024178 — VIATORR ENDOPROSTHESIS
- K014215 — VIABIL BILIARY ENDOPROSTHESIS
- K023811 — MODIFICATION TO VIABAHN ENDOPROSTHESIS
- K023679 — GORE 3.0T TORSO ARRAY
- K021477 — PRECLUDE MVP DURA SUBSTITUTE
- K022782 — DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
- K013648 — VIABAHN ENDOPROSTHESIS
- K013346 — GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
- K013282 — GORE INTRODUCER SHEATH
- K013810 — CARDIOVASCULAR ARRAY
- K013250 — GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
- K012098 — PRECLUDE PERICARDIAL MEMBRANE
- K010936 — MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K010228 — GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
- K001789 — SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K000185 — GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
- K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT
- K992189 — GORE-TEX DUALMESH BIOMATERIAL
- K991602 — EPTFE RINGED GORE-TEX VASCULAR GRAFT
- K984526 — ACUSEAL CARDIOVASCULAR PATCH
- K984534 — PRECLUDE ACUSEAL DURA SUBSTITUTE
- K983525 — GORE REVOX THYROPLASTY IMPLANT
- K981051 — SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
- K973594 — GORE RESOLUT XT REGENERATIVE MATERIAL
- K964067 — GORE IRRIGATION SET
- K970884 — RESOLUT REGENERATIVE MATERIAL
- K964061 — GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
- K965038 — GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
- K964761 — S.A.M. FACIAL IMPLANT W/INTRODUCER
- K963619 — GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
- K962624 — RESOLUT REGENERATIVE MATERIAL
- K961628 — MINI FLEX COIL
- K962401 — GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
- K962241 — GORE SPHEREX IMPLANT
- K960656 — GORE BURR HOLE COVER
- K961802 — PRECLUDE SYNBLOC MEMBRANE
- K961210 — SAM FACIAL IMPLANT
- K960532 — PRECLUDE IMA SLEEVE
- K955533 — DIASTAT VASCULAR ACCESS GRAFT
- K960292 — GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
- K955532 — DIASTAT VASCULAR ACCESS GRAFT
- K955364 — SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K955494 — GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
- K952898 — GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
- K953969 — PRECLUDE DURA SUBSTITUTE
- K951675 — GORE-TEX MYCROMESH BIOMATERIAL
- K951676 — GORE-TEX DUALMESH BIOMATERIAL
- K951700 — GORE-TEX SOFT TISSUE PATCH
- K953287 — DIASTAT VASCULAR ACCESS GRAFT
- K953288 — DIASTAT VASCULAR ACCESS GRAFT
- K951163 — GORE SMOOTHER GUIDED RASP
- K946106 — GORE-TEX DUALMESH PLUS BIOMATERIAL
- K946107 — GORE-TEX MYCROMESH PLUS BIOMATERIAL
- K932866 — RESOLUT REGENERATIVE MATERIAL
- K946267 — GORE-TEX SAM FACIAL IMPLANT
- K945953 — GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.