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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: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2017233
DUNS Number: —

Catalogue (1343)

Page 14 of 27

Device	Model / Reference	Registries	Class	Status
GORE-TEX Stretch Vascular Graft	S0607	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis	VBCR061502A	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RLT281214	FDA UDI	Class III	Active
GORE® DrySeal Flex Introducer Sheath	GDSF1865	FDA UDI	Class II	Active
GORE EXCLUDER Conf AAA Endo - Aortic Extender	CXA360005	FDA UDI	Class III	Active
GORE TAG Conformable Thoracic Stent Graft	TGM342815	FDA UDI	Class III	Active
GORE-TEX Vascular Graft	V08100L	FDA UDI	Class II	Unknown
GORE TAG Thoracic Branch Endoprosthesis	TAC084020A	FDA UDI	Class III	Active
GORE PRECLUDE Pericardial Membrane	1PCM101	FDA UDI	Class II	Unknown
GORE VIABAHN Endoprosthesis	VBC060502	FDA UDI	Class III	Unknown
GORE VIABAHN Endoprosthesis with Heparin	VBJ072502	FDA UDI	Class III	Unknown
GORE VIABAHN Endoprosthesis with Heparin	VBJ071502	FDA UDI	Class III	Unknown
GORE PRECLUDE PDX Dura Substitute	1PDX305	FDA UDI	Class II	Unknown
GORE VIABAHN Endoprosthesis	VBCR071001A	FDA UDI	Class III	Active
GORE VIABIL Biliary Endoprosthesis	VH0808040	FDA UDI	Class II	Active
GORE TAG Thoracic Branch Endoprosthesis	TAC084520A	FDA UDI	Class III	Active
GORE VIABAHN Endoprosthesis with Heparin	VBHR131002A	FDA UDI	Class III	Active
GORE DRYSEAL FLEX Introducer Sheath	DSF1665	FDA UDI	Class II	Active
TIGRIS Vascular Stent	PHA070601A	FDA UDI	Class III	Unknown
GORE DRYSEAL FLEX Introducer Sheath	DSF1265	FDA UDI	Class II	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RMT281414	FDA UDI	Class III	Unknown
GORE EXCLUDER AAA Endoprosthesis	PXC121000	FDA UDI	Class III	Active
GORE-TEX Vascular Graft	ST0805	FDA UDI	Class II	Unknown
GORE-TEX Stretch Vascular Graft-Bifurcated	SB2001D	FDA UDI	Class II	Unknown
GORE-TEX Vascular Graft	SRD06005045L	FDA UDI	Class II	Active
GORE® DrySeal Flex Introducer Sheath	GDSF1633	FDA UDI	Class II	Active
GORE CARDIOFORM Septal Occluder	GSX0020A	FDA UDI	Class III	Active
GORE-TEX Vascular Graft	SRRT06010010L	FDA UDI	Class II	Active
TIGRIS Vascular Stent	PHA060602A	FDA UDI	Class III	Unknown
GORE-TEX Vascular Graft	V05070L	FDA UDI	Class II	Unknown
GORE VIABAHN Endoprosthesis	VBC061502	FDA UDI	Class III	Unknown
GORE DRYSEAL Sheath	DSL2428	FDA UDI	Class II	Unknown
GORE VIABAHN VBX Balloon Expandable Endo	BXA077902A	FDA UDI	Class III	Active
GORE PROPATEN Vascular Graft	HT063070A	FDA UDI	Class II	Active
GORE SYNECOR Preperitoneal Biomaterial	GKWR1215	FDA UDI	Class II	Active
GORE SYNECOR Preperitoneal Biomaterial	GKWR3030	FDA UDI	Class II	Active
GORE TAG Thoracic Endoprosthesis	TGT3420	FDA UDI	Class III	Unknown
GORE VIABIL Biliary Endoprosthesis	VN0808200	FDA UDI	Class II	Active
GORE PROPATEN Vascular Graft Pediatric Shunt	HPT040005A	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis with Heparin	VBHR081502A	FDA UDI	Class III	Active
GORE PRECLUDE Dura Substitute	1PDS152	FDA UDI	Class II	Active
GORE-TEX Vascular Graft	SRRT06070070L	FDA UDI	Class II	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RMT261412	FDA UDI	Class III	Unknown
GORE-TEX Vascular Graft	SRRT08030080L	FDA UDI	Class II	Unknown
GORE-TEX Suture	7M12	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis with Heparin	VBHR071501A	FDA UDI	Class III	Active
GORE VIABAHN Endoprosthesis with Heparin	VBJR050502A	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RLT351414	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA063901A	FDA UDI	Class III	Active
GORE VIABIL Biliary Endoprosthesis	VN1008200	FDA UDI	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.