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W L Gore & Associates, Inc.
W L Gore & Associates, Inc.: 29 FDA recall reports
Every medical device recall the FDA has published for W L Gore & Associates, Inc.. The fault, and how the agency graded it.
29Reports
0Class I
23Ongoing
2026-07-08Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (i
Z-2672-2026 · Class II · reported 2026-07-08 · Ongoing
- Why it was recalled
- Due to catheter separation
- Product
- GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE¿ TAG¿ Conformable Thoracic Endoprosthesis to accommodate the intended...
- Where it went
- 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.
- How much
- 467 devices
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH0
Z-0036-2026 · Class II · reported 2025-10-08 · Ongoing
- Why it was recalled
- 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.
- Product
- GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
- Where it went
- 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
- How much
- 52,306
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United S
Z-2945-2024 · Class II · reported 2024-09-11 · Ongoing
- Why it was recalled
- Due to packaging defects, sterility assurance and heparin activity may be compromised.
- Product
- Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
- Where it went
- 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.
- How much
- 42,901 units
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United S
Z-2946-2024 · Class II · reported 2024-09-11 · Ongoing
- Why it was recalled
- Due to packaging defects, sterility assurance and heparin activity may be compromised.
- Product
- Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
- Where it went
- 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.
- How much
- 100 units
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number:
Z-2513-2024 · Class II · reported 2024-08-14 · Ongoing
- Why it was recalled
- Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
- Product
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
- Where it went
- US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
- How much
- 51 units
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm
Z-1179-2024 · Class II · reported 2024-02-28 · Ongoing
- Why it was recalled
- 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.
- Product
- GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
- Where it went
- US Nationwide distribution in the state of Georgia.
- How much
- 24
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Z-1048-2023 · Class II · reported 2023-02-08 · Ongoing
- Why it was recalled
- 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.
- Product
- GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Where it went
- US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
- How much
- 14
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Z-0136-2023 · Class II · reported 2022-11-02 · Ongoing
- Why it was recalled
- Due to manufacturing records (Release Test Results) indicating "Failed".
- Product
- GORE CARDIOFORM ASD Occluder. cardiovascular implant.
- Where it went
- 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.
- How much
- 98 units
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm,
Z-0172-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
- Where it went
- 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
- How much
- 15 units
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm,
Z-0166-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
- Where it went
- 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
- How much
- N/A
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm,
Z-0169-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
- Where it went
- 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
- How much
- 846 units
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm,
Z-0165-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
- Where it went
- 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
- How much
- 138 units
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm,
Z-0170-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
- Where it went
- 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
- How much
- 187 units
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm,
Z-0171-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
- Where it went
- 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
- How much
- 222 units
REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm,
Z-0167-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
- Where it went
- 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
- How much
- 95 units
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm,
Z-0164-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
- Where it went
- 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
- How much
- 2,238 units
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm,
Z-0168-2022 · Class II · reported 2021-11-03 · Ongoing
- Why it was recalled
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Product
- REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
- Where it went
- 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
- How much
- 1268 unit
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOO
Z-0077-2022 · Class II · reported 2021-10-20 · Ongoing
- Why it was recalled
- 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.
- Product
- Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
- Where it went
- International distribution to the countries of Italy & Lebanon.
- How much
- 2 units
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidew
Z-2340-2021 · Class II · reported 2021-09-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
- Where it went
- 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.
- How much
- 3,364 units
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO
Z-2292-2021 · Class II · reported 2021-08-25 · Ongoing
- Why it was recalled
- 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.
- Product
- Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
- Where it went
- US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia
- How much
- N/A
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO
Z-2293-2021 · Class II · reported 2021-08-25 · Ongoing
- Why it was recalled
- 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.
- Product
- Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
- Where it went
- US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia
- How much
- N/A
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH100
Z-1593-2021 · Class II · reported 2021-05-26 · Terminated
- Why it was recalled
- The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
- Product
- GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
- Where it went
- 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.
- How much
- 61 devices
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Z-0291-2021 · Class II · reported 2020-11-04 · Ongoing
- Why it was recalled
- 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.
- Product
- GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Where it went
- U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom
- How much
- 19013 units
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Z-0290-2021 · Class II · reported 2020-11-04 · Ongoing
- Why it was recalled
- Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
- Product
- GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
- Where it went
- U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom
- How much
- 13860 units
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascula
Z-2052-2020 · Class II · reported 2020-05-27 · Terminated
- Why it was recalled
- The incorrect label was placed on both the primary and secondary package.
- Product
- Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
- Where it went
- International the country of Japan.
- How much
- 15 stents
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label
Z-1962-2020 · Class II · reported 2020-05-20 · Terminated
- Why it was recalled
- The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
- Product
- Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
- Where it went
- All distribution is foreign to the following countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK.
- How much
- 141 devices
GORE¿ EXCLUDER¿ AAA Endoprosthesis
Z-0995-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- Firm has received reports of leading end catheter component separations.
- Product
- GORE¿ EXCLUDER¿ AAA Endoprosthesis
- Where it went
- US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Netherlands; Norway; Finland; France; Sweden; Monaco;
- How much
- 255861 units
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Z-0996-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- Firm has received reports of leading end catheter component separations.
- Product
- GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
- Where it went
- US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Netherlands; Norway; Finland; France; Sweden; Monaco;
- How much
- 23212 units
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endo
Z-0048-2018 · Class II · reported 2017-11-01 · Terminated
- Why it was recalled
- Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
- Product
- GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
- Where it went
- Worldwide.
- How much
- 12,197units
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls