W. L. Gore & Associates, Inc.
United States US-MF-000001141 Last updated 25 Oct 2026
- Devices
- 2,172
- Registries
- EUDAMEDFDA
- FDA recalls
- 3226 ongoing
Catalogue
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB075902E
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Ref PAJR050502E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXA073901E
GORE® VIABAHN® Endoprosthesis Ref PAC050502
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXA102901E
GORE® VIABAHN® Endoprosthesis Ref PACR061001E
GORE-TEX® Stretch Vascular Graft Ref SA1604E
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Ref PAJR061002E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB093902E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB097901E
GORE® EXCLUDER® Iliac Branch Endoprosthesis Ref CEB231210
GORE® DUALMESH® Biomaterial Ref 1DLMC06E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXA071502E
GORE-TEX® Stretch Vascular Graft Ref ST0704E
GORE® TIGRIS® Vascular Stent Ref PHB071002
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXA052901E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXBL087901E
GORE® VIABAHN® Endoprosthesis Ref PAC131002
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB117902E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB051501E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXAL083901E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXA057902E
GORE® DrySeal Flex Introducer Sheath Ref DSF2365
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Ref PAHR070201E
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Ref PAJR062502E
GORE-TEX® Stretch Vascular Graft Ref ST0804E
GORE® EXCLUDER® Conformable AAA Endoprosthesis Ref CXT231416E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB092902E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB103902E
GORE-TEX® Stretch Vascular Graft Ref ST0407E
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Ref PAHR071502E
GORE-TEX® Stretch Vascular Graft Ref S46045E
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Ref PAHR062502E
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Ref PAHR051502E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB113902E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXA117902E
GORE® EXCLUDER® Iliac Branch Endoprosthesis Ref CEB231410
GORE® EXCLUDER® Conformable AAA Endoprosthesis Ref CXT281414E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB112902E
GORE® INTERING® Vascular Graft Ref IRS06005045LE
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Ref PAHR071501E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB095901E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB057901E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB115901E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXAL085901E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXA065901E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXB083902E
GORE-TEX® Stretch Vascular Graft Ref ST0608E
GORE-TEX® Stretch Vascular Graft Ref S0605E
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Ref BXA093901E
Showing 1-50 of 2,172
EUDAMED certificates
Notified body 2797 9 certificates
- MDR 731002 Reissued
Technical documentation EU MDR
- Issued
- 20 Jul 2026
- Expires
- 16 Aug 2031
- Valid from
- 17 Aug 2026
- MDR 731175 Reissued
Technical documentation EU MDR
- Issued
- 20 Jul 2026
- Expires
- 19 Jul 2031
- MDR 731176 Reissued
Technical documentation EU MDR
- Issued
- 20 Jul 2026
- Expires
- 19 Jul 2031
- MDR 731178 Reissued
Technical documentation EU MDR
- Issued
- 20 Jul 2026
- Expires
- 19 Jul 2031
- MDR 731181 Reissued
Technical documentation EU MDR
- Issued
- 20 Jul 2026
- Expires
- 19 Jul 2031
- MDR 732281 Reissued
Technical documentation EU MDR
- Issued
- 20 Jul 2026
- Expires
- 19 Jul 2031
- MDR 764343 Supplemented
Technical documentation EU MDR
- Issued
- 20 Aug 2026
- Expires
- 26 Apr 2028
- Reason
- Add device or group
- MDR 732278 Supplemented
Technical documentation EU MDR
- Issued
- 18 Jun 2026
- Expires
- 20 Feb 2027
- Reason
- Other
- MDR 732282 Supplemented
Technical documentation EU MDR
- Issued
- 31 Aug 2026
- Expires
- 20 Feb 2027
- Reason
- Change approved
Related companies
Notified bodies
- Notified body 2797
FDA recalls
2026
- 3 Sep 2026 Z-0158-2027 Not yet classified Ongoing The potential for the devices to be mislabeled with the incorrect length.
- 22 May 2026 Z-2914-2026 Class II Ongoing 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
- 22 May 2026 Z-2915-2026 Class II Ongoing 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
- 19 May 2026 Z-2672-2026 Class II Ongoing Due to catheter separation
2025
- 26 Aug 2025 Z-0036-2026 Class II Ongoing 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.
2024
- 3 Jul 2024 Z-2513-2024 Class II Ongoing Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
- 1 Jul 2024 Z-2945-2024 Class II Ongoing Due to packaging defects, sterility assurance and heparin activity may be compromised.
- 1 Jul 2024 Z-2946-2024 Class II Ongoing Due to packaging defects, sterility assurance and heparin activity may be compromised.
- 19 Jan 2024 Z-1179-2024 Class II Ongoing 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.
2022
- 14 Dec 2022 Z-1048-2023 Class II Ongoing 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.
Show the 25 most recent of 32 recalls
2022
- 21 Sep 2022 Z-0136-2023 Class II Ongoing Due to manufacturing records (Release Test Results) indicating "Failed".
2021
- 7 Sep 2021 Z-0077-2022 Class II Ongoing 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.
- 2 Sep 2021 Z-0164-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 2 Sep 2021 Z-0165-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 2 Sep 2021 Z-0166-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 2 Sep 2021 Z-0167-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 2 Sep 2021 Z-0168-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 2 Sep 2021 Z-0169-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 2 Sep 2021 Z-0170-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 2 Sep 2021 Z-0171-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 2 Sep 2021 Z-0172-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- 12 Jul 2021 Z-2340-2021 Class II Ongoing 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.
- 12 May 2021 Z-2292-2021 Class II Ongoing 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.
- 12 May 2021 Z-2293-2021 Class II Ongoing 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.
- 5 Apr 2021 Z-1593-2021 Class II Terminated The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length.
FDA establishments
- W. L. Gore & Associates, Inc FLAGSTAFF, AZ · US FEI 2017233
Information
- Country
- United States
- Address
- 1505, North Fourth Street, Flagstaff, Arizona, United States
- Website
- wlgore.com
- [email protected]
- PRRC contact
- Tim Raban
- EUDAMED SRN
- US-MF-000001141
- FDA FEI number
- 3003910212