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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
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EUDAMED SRN: —
FDA FEI Number: 2017233
DUNS Number: —

Catalogue (1343)

Page 7 of 27

Device	Model / Reference	Registries	Class	Status
GORE VIABAHN Endoprosthesis with Heparin	VBJR070502A	FDA UDI	Class III	Active
GORE SYNECOR Biomaterial	GKFC12	FDA UDI	Class II	Active
GORE PROPATEN Vascular Graft Pediatric Shunt	HPT040010A	FDA UDI	Class II	Active
Gore Dualmesh Plus Biomaterial	1DLMCP02	FDA UDI	Class II	Unknown
GORE VIABAHN VBX Balloon Expandable Endo	BXA072902A	FDA UDI	Class III	Active
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce	BSGUSS45GAC	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis with Heparin	VBJR080502A	FDA UDI	Class III	Active
GORE PROPATEN Vascular Graft	HT066070A	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis with Heparin	VBHR051502A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXB051902A	FDA UDI	Class III	Active
GORE-TEX Suture	7M02	FDA UDI	Class II	Active
GORE PROPATEN Vascular Graft Pediatric Shunt	HPT050015A	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis	VBCR080502A	FDA UDI	Class III	Active
GORE-TEX Vascular Graft	ST35015A	FDA UDI	Class II	Active
GORE BIO-A Hernia Plug	HP01	FDA UDI	Class II	Unknown
GORE-TEX Stretch Vascular Graft	S0603	FDA UDI	Class II	Active
GORE-TEX Suture	2U05	FDA UDI	Class II	Active
GORE-TEX Vascular Graft	ST0704	FDA UDI	Class II	Active
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce	BSGUSS60GAC	FDA UDI	Class II	Active
GORE-TEX Vascular Graft	SRRT08070080L	FDA UDI	Class II	Active
GORE® ACUSEAL Cardiovascular Patch	1CVX002	FDA UDI	Class II	Active
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce	1OBSGPROX55	FDA UDI	Class II	Unknown
GORE VIABAHN VBX Balloon Expandable Endo	BXB051901A	FDA UDI	Class III	Active
GORE TAG Conformable Thoracic Stent Graft	TGM262110	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXB061502A	FDA UDI	Class III	Active
GORE VIABAHN Endoprosthesis	VBC051002	FDA UDI	Class III	Unknown
GORE VIABAHN VBX Balloon Expandable Endo	BXBL085902A	FDA UDI	Class III	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXB062901A	FDA UDI	Class III	Active
GORE TAG Thoracic Branch Endoprosthesis	TE2840A	FDA UDI	Class III	Active
GORE EXCLUDER AAA Endoprosthesis	PLC141200	FDA UDI	Class III	Active
GORE-TEX Suture	2U17	FDA UDI	Class II	Active
GORE EXCLUDER AAA Endoprosthesis	PLC181000	FDA UDI	Class III	Active
GORE INTERING Vascular Graft	IRST08060060L	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis with Heparin	VBH131002A	FDA UDI	Class III	Active
GORE VIABAHN Endoprosthesis	VBC050202	FDA UDI	Class III	Unknown
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RMT261214	FDA UDI	Class III	Unknown
GORE-TEX Vascular Graft	V08090L	FDA UDI	Class II	Unknown
GORE VIABAHN Endoprosthesis with Heparin	VBHR080201A	FDA UDI	Class III	Active
GORE PRECLUDE PDX Dura Substitute	1PDX300	FDA UDI	Class II	Unknown
GORE VIABIL Biliary Endoprosthesis	VH0806200	FDA UDI	Class II	Active
GORE PROPATEN Vascular Graft	HT087090A	FDA UDI	Class II	Active
GORE VIABIL Biliary Endoprosthesis	VN1008040	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis	VBC091502A	FDA UDI	Class III	Active
GORE INTERING Vascular Graft	IRS46045L	FDA UDI	Class II	Active
GORE-TEX Vascular Graft	SRRT06030040L	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis with Heparin	VBHR111002A	FDA UDI	Class III	Active
GORE PROPATEN Vascular Graft	IRTH084040A	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis	VBC051502	FDA UDI	Class III	Unknown
GORE VIABAHN Endoprosthesis with Heparin	VBH090502A	FDA UDI	Class III	Active
GORE PROPATEN Vascular Graft Pediatric Shunt	HPT030005A	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.