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W. L. GORE & ASSOCIATES, INC

Last updated September 17, 2026

Information

Country: US
Address: 1505 NORTH FOURTH ST., FLAGSTAFF, AZ, 86004
Website: —
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EUDAMED SRN: —
FDA FEI Number: 2017233
DUNS Number: —

Catalogue (1343)

Page 27 of 27

Device	Model / Reference	Registries	Class	Status
GORE VIABAHN VBX Balloon Expandable Endo	BXA095902A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA083902A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXB083901A	FDA UDI	Class III	Active
GORE ENFORM Preperitoneal Biomaterial	GBWR2540	FDA UDI	Class II	Active
GORE-TEX Suture Oral Health	P7K13	EUDAMEDFDA UDI	Class II	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RLT261416	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RMT281212	FDA UDI	Class III	Unknown
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce	1OBSGDST60	FDA UDI	Class II	Unknown
GORE TAG Conformable Thoracic Endoprosthesis	TGU454520	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXB095902A	FDA UDI	Class III	Active
GORE TAG Thoracic Branch Endoprosthesis	TAC083420A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA052901A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXB063902A	FDA UDI	Class III	Active
GORE INTERING Vascular Graft	IRS06010020L	FDA UDI	Class II	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA051901A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA085901A	FDA UDI	Class III	Active
GORE TAG Thoracic Branch Endoprosthesis	TSB081006A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA062901A	FDA UDI	Class III	Active
GORE TAG Thoracic Branch Endoprosthesis	TAC124015A	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RLT311415	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RLT261216	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA093901A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA092901A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA103902A	FDA UDI	Class III	Active
GORE TAG Conformable Thoracic Stent Graft	TGM282815	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RMT281216	FDA UDI	Class III	Unknown
GORE VIABAHN VBX Balloon Expandable Endo	BXB063901A	FDA UDI	Class III	Active
GORE TAG Conformable Thoracic Stent Graft	TGM343420	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA075902A	FDA UDI	Class III	Active
GORE TAG Thoracic Branch Endoprosthesis	TE3442A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA095901A	FDA UDI	Class III	Active
GORE TAG Conformable Thoracic Endoprosthesis	TGU343420	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RLT261218	FDA UDI	Class III	Active
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce	BSGEC45AC	FDA UDI	Class II	Active
GORE TAG Thoracic Branch Endoprosthesis	TE4043A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXB093901A	FDA UDI	Class III	Active
GORE TAG Conformable Thoracic Stent Graft	TGMR313120	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RMT231212	FDA UDI	Class III	Unknown
GORE TAG Conformable Thoracic Stent Graft	TGM212110	FDA UDI	Class III	Active
GORE CARDIOFORM ASD Occluder	ASD44A	FDA UDI	Class III	Active
Gore(r) Embolic Filter	K120480	FDA 510(k)	Class II	Active
Gore Hybrid Vascular Graft	K093934	FDA 510(k)	Class II	Active
Gore Seamguard Bioabsorbable Staple Line Reinforcement Material	K053202	FDA 510(k)	Class II	Active

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FDA Recalls (28)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 26, 2025	Z-0036-2026	—	open, classified	Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
Jul 3, 2024	Z-2513-2024	—	open, classified	Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Jul 1, 2024	Z-2946-2024	—	open, classified	Due to packaging defects, sterility assurance and heparin activity may be compromised.
Jul 1, 2024	Z-2945-2024	—	open, classified	Due to packaging defects, sterility assurance and heparin activity may be compromised.
Jan 19, 2024	Z-1179-2024	—	open, classified	Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
Dec 14, 2022	Z-1048-2023	—	open, classified	Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
Sep 21, 2022	Z-0136-2023	—	open, classified	Due to manufacturing records (Release Test Results) indicating "Failed".
Sep 7, 2021	Z-0077-2022	—	open, classified	Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Sep 2, 2021	Z-0171-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021	Z-0168-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021	Z-0169-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021	Z-0165-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021	Z-0170-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021	Z-0164-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021	Z-0172-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021	Z-0166-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021	Z-0167-2022	—	open, classified	Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Jul 12, 2021	Z-2340-2021	—	open, classified	Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
May 12, 2021	Z-2293-2021	—	open, classified	Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
May 12, 2021	Z-2292-2021	—	open, classified	Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Apr 5, 2021	Z-1593-2021	—	terminated	The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length.
Sep 9, 2020	Z-0290-2021	—	open, classified	Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
Sep 9, 2020	Z-0291-2021	—	open, classified	When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Jan 6, 2020	Z-0996-2020	—	terminated	Firm has received reports of leading end catheter component separations.
Jan 6, 2020	Z-0995-2020	—	terminated	Firm has received reports of leading end catheter component separations.
Dec 17, 2019	Z-2052-2020	—	terminated	The incorrect label was placed on both the primary and secondary package.
Nov 18, 2019	Z-1962-2020	—	terminated	The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Sep 25, 2017	Z-0048-2018	—	terminated	Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.