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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 9 of 27

Device	Model / Reference	Registries	Class	Status
GORE® DrySeal Flex Introducer Sheath	GDSF2433	FDA UDI	Class II	Active
GORE SYNECOR Preperitoneal Biomaterial	GKWR4040	FDA UDI	Class II	Active
GORE VIABIL Biliary Endoprosthesis	VSWVN1010	FDA UDI	Class II	Active
GORE DRYSEAL FLEX Introducer Sheath	DSF1033	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis	VBC101002A	FDA UDI	Class III	Active
GORE CARDIOFORM Septal Occluder	GSX0025A	FDA UDI	Class III	Active
GORE-TEX Vascular Graft	RRT08040050L	FDA UDI	Class II	Unknown
GORE VIABAHN Endoprosthesis	VBC131002	FDA UDI	Class III	Unknown
GORE VIABAHN VBX Balloon Expandable Endo	BXB072901A	FDA UDI	Class III	Active
GORE MYCROMESH PLUS Biomaterial	1MYMP17	FDA UDI	Class II	Unknown
GORE VIABAHN Endoprosthesis	VBC060202	FDA UDI	Class III	Unknown
GORE-TEX Vascular Graft	SRRT08030040L	FDA UDI	Class II	Active
GORE-TEX Vascular Graft	V46050L	FDA UDI	Class II	Active
GORE-TEX Suture	2M25	FDA UDI	Class II	Active
GORE VIATORR TIPS Endoprosthesis	PTB085275	FDA UDI	Class III	Unknown
GORE EXCLUDER AAA Endoprosthesis	PXA230300	FDA UDI	Class III	Unknown
GORE-TEX Vascular Graft	VT08070L	FDA UDI	Class II	Unknown
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RMT261414	FDA UDI	Class III	Unknown
GORE-TEX Vascular Graft	V06030L	FDA UDI	Class II	Active
GORE PROPATEN Vascular Graft	IRTH066060A	FDA UDI	Class II	Active
GORE VIABIL Biliary Endoprosthesis	VN1004040	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis	VBC080502	FDA UDI	Class III	Unknown
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RLT281412	FDA UDI	Class III	Active
GORE PRECLUDE PDX Dura Substitute	1PDX306	FDA UDI	Class II	Unknown
GORE VIABAHN VBX Balloon Expandable Endo	BXA053901A	FDA UDI	Class III	Active
GORE TAG Conformable Thoracic Stent Graft	TGM343410	FDA UDI	Class III	Active
GORE ENFORM Preperitoneal Biomaterial	GBWR1010	FDA UDI	Class II	Active
GORE-TEX Suture	7J02	FDA UDI	Class II	Active
GORE DRYSEAL FLEX Introducer Sheath	DSF1533	FDA UDI	Class II	Active
GORE VIABAHN Endoprosthesis with Heparin	VBHR060202A	FDA UDI	Class III	Active
GORE MYCROMESH PLUS Biomaterial	1MYMP09	FDA UDI	Class II	Unknown
GORE SYNECOR Preperitoneal Biomaterial	GKWR2025	FDA UDI	Class II	Active
GORE-TEX Stretch Vascular Graft	S0704	FDA UDI	Class II	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXAL085902A	FDA UDI	Class III	Active
GORE VIABAHN Endoprosthesis with Heparin	VBH101502A	FDA UDI	Class III	Active
GORE VIABAHN Endoprosthesis with Heparin	VBJ050202	FDA UDI	Class III	Active
GORE-TEX Vascular Graft	ST0708	FDA UDI	Class II	Active
GORE PROPATEN Vascular Graft	IRH463845A	FDA UDI	Class II	Active
GORE-TEX Vascular Graft	RR06030070L	FDA UDI	Class II	Unknown
GORE VIABAHN Endoprosthesis	VBC090502A	FDA UDI	Class III	Active
GORE VIABAHN Endoprosthesis with Heparin	VBHR060501A	FDA UDI	Class III	Active
GORE VIABIL Biliary Endoprosthesis	VN0808040	FDA UDI	Class II	Active
GORE-TEX Vascular Graft	V08050L	FDA UDI	Class II	Active
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery	RLT261212	FDA UDI	Class III	Active
GORE VIABAHN Endoprosthesis with Heparin	VBH131002	FDA UDI	Class III	Active
GORE DrySeal Sheath	SDV1828	FDA UDI	Class II	Unknown
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce	1OBSGPROX100	FDA UDI	Class II	Unknown
GORE DRYSEAL FLEX Introducer Sheath	DSF1833	FDA UDI	Class II	Active
GORE-TEX Vascular Graft	V06020L	FDA UDI	Class II	Active
GORE VIABAHN VBX Balloon Expandable Endo	BXA062902A	FDA UDI	Class III	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.