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W. L. Gore & Associates, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000001141 FEI 3003910212

Devices
2,172
Registrations
EUDAMEDFDA
FDA recalls
3224 ongoing since 2021 (26 open in total)
2 open since before 2021

Catalogue2,172

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Company details

EUDAMED SRN
US-MF-000001141
FDA FEI number
3003910212
EUDAMED status
Active
EUDAMED registered name
W. L. Gore & Associates, Inc.
EUDAMED abbreviated name
Gore Inc.
Registered address
1505, North Fourth Street, 86004, Flagstaff, Arizona, United States
PRRC contact
Tim Raban(public in EUDAMED)

EUDAMED certificates9

9 certificates9 valid, 0 expiredMDR 9next expiry 20 Feb 2027

EUDAMED certificates (9)

BSI Group The Netherlands B.V. 2797 9 certificates

  • MDR 731002 Active Reissued

    Technical documentation EU MDR

    Issued
    20 Jul 2026
    Expires
    16 Aug 2031
    Valid from
    17 Aug 2026
  • MDR 731175 Active Reissued

    Technical documentation EU MDR

    Issued
    20 Jul 2026
    Expires
    19 Jul 2031
  • MDR 731176 Active Reissued

    Technical documentation EU MDR

    Issued
    20 Jul 2026
    Expires
    19 Jul 2031
  • MDR 731178 Active Reissued

    Technical documentation EU MDR

    Issued
    20 Jul 2026
    Expires
    19 Jul 2031
  • MDR 731181 Active Reissued

    Technical documentation EU MDR

    Issued
    20 Jul 2026
    Expires
    19 Jul 2031
  • MDR 732281 Active Reissued

    Technical documentation EU MDR

    Issued
    20 Jul 2026
    Expires
    19 Jul 2031
  • MDR 764343 Active Supplemented

    Technical documentation EU MDR

    Issued
    20 Aug 2026
    Expires
    26 Apr 2028
    Reason
    Add device or group
  • MDR 732278 Expiring Supplemented Expires in 111 days

    Technical documentation EU MDR

    Issued
    18 Jun 2026
    Expires
    20 Feb 2027
    Reason
    Other
  • MDR 732282 Expiring Supplemented Expires in 111 days

    Technical documentation EU MDR

    Issued
    31 Aug 2026
    Expires
    20 Feb 2027
    Reason
    Change approved

FDA recalls32

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 2
  • 2020 4
  • 2021 14
  • 2022 2
  • 2023 0
  • 2024 4
  • 2025 1
  • 2026 4

Showing the 10 most recent of 32 recalls.

  • 2026

    • 3 Sep 2026 Z-0158-2027 Class II Ongoing The potential for the devices to be mislabeled with the incorrect length.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US Nationwide distribution in the states of GA, RI. Submission number: K170740
    • 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).via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: U.S. Nationwide distribution in the states of GA and RI. Submission number: K170740
    • 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).via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: U.S. Nationwide distribution in the states of GA and RI. Submission number: K170740
    • 19 May 2026 Z-2672-2026 Class II Ongoing Due to catheter separationvia FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI. The countries of United Arab Emirates, Australia, Austria, Canada, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Monaco, Malta, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovakia, Sweden, and Taiwan.
      Submission number: P210032

  • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI,…
      Full distribution text US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI, NY, DC, SC, CT, NE, IA, WA, AR, NV, WV, AK, UT, ND, KS, CO, ME, MT, NM, SD, PR, WY, RI. OUS: PANAMA, CANADA, CHINA, TAIWAN, GERMANY, SLOVENIA, NORWAY, UNITED KINGDOM, ITALY, SPAIN, FINLAND, NETHERLANDS, SWEDEN, FRANCE, UNITED ARAB EMIRATES, DENMARK, PORTUGAL, AUSTRIA, SWITZERLAND, BELGIUM, TURKIYE, SLOVAK REPUBLIC, CYPRUS, SAUDI ARABIA, SOUTH AFRICA, LUXEMBOURG, FRENCH GUIANA, ANDORRA, IRELAND, NEW CALEDONIA, POLAND, ISRAEL, GREECE, GUADELOUPE, CROATIA, REUNION, BAHRAIN, HUNGARY, JAPAN
      Submission number: K233551

  • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA. Submission number: K053200
    • 1 Jul 2024 Z-2945-2024 Class II Ongoing Due to packaging defects, sterility assurance and heparin activity may be compromised.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
    • 1 Jul 2024 Z-2946-2024 Class II Ongoing Due to packaging defects, sterility assurance and heparin activity may be compromised.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US Nationwide distribution in the state of Georgia. Submission number: K170740

  • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
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".via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME,…
      Full distribution text Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.

  • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: International distribution to the countries of Italy & Lebanon. Submission number: P160021
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AUS, CAN, CHE, DEU, DNK, ESP, FIN, FRA, GBR, GRC, HRV, HUN, IRL, ISR, ITA, JPN, MEX, NLD, NOR, POL, PRT, SMR, SWE.
      Submission number: K172567
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia Submission number: K062161
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia Submission number: K062161
    • 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.via FDA establishment W. L. GORE & ASSOCIATES, INC Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy.
      Submission number: K081184

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • W. L. Gore & Associates, Inc FLAGSTAFF, AZ · US FEI 2017233

Frequently asked questions

How many devices does W. L. Gore & Associates, Inc. have in the registry?

The registry currently lists 2172 devices for W. L. Gore & Associates, Inc.. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for W. L. Gore & Associates, Inc.?

FDA recall records list 32 recalls initiated by W. L. Gore & Associates, Inc., the most recent initiated on 3 Sep 2026. 26 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for W. L. Gore & Associates, Inc.?

EUDAMED lists 9 certificates for W. L. Gore & Associates, Inc. (technical documentation) under MDR. The most recent was issued on 31 Aug 2026.

Which FDA establishments are linked to W. L. Gore & Associates, Inc.?

1 FDA establishment is linked to W. L. Gore & Associates, Inc. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.