Class 2 Device Recall GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN Endoprosthesis with PRO

• Date Initiated by Firm: August 28, 2026
• Date Posted: November 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0360-2027
• Recall Event ID: 99797
• PMA Number: P040037 P130006
• Product Classification: Stent, superficial femoral artery - Product Code NIP
• Product: Brand Name: GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface Product Name: GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface Model/Catalog Number: VBJR081002A, VBJR081502A, VBJR060702A, VBJR071002A, PAJR081002B, VBJR080702A, VBJR072502A, VBJR082502A, PAHR131002B, PAJR071002B, VBJR080502A, VBJR061502A, VBJR051502A, VBJR062502A, VBHR111002A, VBJR052502A, VBJR051002A, VBHR110502A, VBHR131002A, VBHR131002H, VBHR110502W, VBHR131002W, JHJR060702J, JHJR071002J, PAJR081002E, PAHR131002E, PAJR061502E, PAJR070502E, PAJR071002E, PAJR062502E, PAJR061002E, PAJR051502E, PAJR070702E, PAHR110502E, PAHR130502E Reference Attachment 6 for an explanation of the part numbers. Product Description: The GORE VIABAHN Endoprosthesis with Heparin/PROPATEN Bioactive Surface is intended for use as an endovascular prosthesis. The endoprosthesis functions as a new blood conduit, with inlet and outlet to the endoprosthesis for blood flow. The self-expanding stent frame serves to maintain an open vessel lumen while the expanded polytetrafluoroethylene (ePTFE) graft material serves as a blood flow conduit. Surface bound heparin on the device is used as an anticoagulant to provide thromboresistance. The GORE VIABAHN Endoprosthesis with Heparin/PROPATEN Bioactive Surface is a flexible, self-expanding endoluminal endoprosthesis consisting of an ePTFE lining with an external nitinol (NiTi = Nickel:Titanium) support extending along its entire length. Four radiopaque markers are present on each end of the endoprosthesis to facilitate accurate placement and improve visibility of the device post-deployment. The CBAS Heparin Surface on the GORE VIABAHN Endoprosthesis with Heparin/PROPATEN Bioactive Surface consists of stable, covalent, end-point attached heparin of porcine origin. The endoprosthesis is compressed and attached to a dual lumen delivery catheter. The larger central catheter lumen is used for flushing and guidewire introduction. The smaller lumen contains elements of the deployment mechanism. The delivery catheter hub assembly has one port for the deployment system and one port for flushing and guidewire insertion. To facilitate accurate endoprosthesis placement, two radiopaque metallic bands are attached to the catheter shaft, marking the ends of the compressed endoprosthesis. Component: N/A
• Code Information: Model Number / UDI-DI code: JHJR060702J 04993024010482 Lot Numbers: 31674434 31674435 31674436 Model Number / UDI-DI code: JHJR071002J 04993024010239 Lot Numbers: 31750021 31724571 Model Number / UDI-DI code: PAHR110502E 00733132650118 Lot Numbers: 31822842 31822830 31822838 31846601 31822836 31846583 31846582 31822843 31822819 31822817 31822831 31846595 31846596 31846592 31822839 31822824 31822825 31822840 31822841 31846591 31846593 31822844 31846585 31846586 31846587 31846600 31846590 31822833 31846597 31822822 31822816 31822826 31822821 31822835 31846589 31846599 31822818 31822820 31846598 31822834 31846594 31822832 31846588 31846584 Model Number / UDI-DI code: PAHR130502E 00733132650132 Lot Numbers: 31832526 31832532 31832529 31832527 31832525 31832528 31832530 Model Number / UDI-DI code: PAHR131002B 00733132650248 Lot Numbers: 31849227 31720620 Model Number / UDI-DI code: PAHR131002E 00733132650149 Lot Numbers: 31822989 31822990 31822986 31704734 31822965 31704735 31822988 31822963 31704732 31822993 31822987 31822967 31822964 31822991 31822992 31822966 31822968 Model Number / UDI-DI code: PAJR051502E 00733132623846 Lot Numbers: 31775425 31775427 31775426 31775428 Model Number / UDI-DI code: PAJR061002E 00733132623983 Lot Numbers: 31761002 31760999 31760997 31760998 31761000 31761003 31761007 31761008 31761001 31760996 31761006 Model Number / UDI-DI code: PAJR061502E 00733132623990 Lot Numbers: 31723358 31723357 31723360 Model Number / UDI-DI code: PAJR062502E 00733132624003 Lot Numbers: 31749884 31775388 31775385 31775386 31775387 Model Number / UDI-DI code: PAJR070502E 00733132627431 Lot Numbers: 31726726 31726709 31726731 31726736 31726700 31726735 31726705 31726708 31726729 31726704 31726732 31726706 31726727 31726728 31726730 31726707 31726698 31726701 31726702 31726734 31726703 31726699 Model Number / UDI-DI code: PAJR070702E 00733132627844 Lot Numbers: 31790107 31790108 31790105 31790106 Model Number / UDI-DI code: PAJR071002B 00733132639618 Lot Numbers: 31723720 31723721 31723718 31723719 Model Number / UDI-DI code: PAJR071002E 00733132627448 Lot Numbers: 31733204 31733211 31733207 31733212 31733213 31733203 31733208 31733206 31733210 31733214 31733209 31733205 Model Number / UDI-DI code: PAJR081002B 00733132639663 Lot Numbers: 31704840 31714266 31704842 31714265 31714264 31714268 31704844 31704841 31704843 31714267 Model Number / UDI-DI code: PAJR081002E 00733132627493 Lot Numbers: 31735027 31658986 31658987 31658985 31735029 31607103 31607104 31607105 31607106 31735026 31735024 Model Number / UDI-DI code: VBHR110502A 00733132646081 Lot Numbers: 31831734 31831738 31831735 31820787 31831730 31831739 Model Number / UDI-DI code: VBHR110502W 00733132651139 Lot Numbers: 31823157 31846809 31823158 31823160 31823161 31846811 31823156 31823159 31846810 31823162 31823163 Model Number / UDI-DI code: VBHR111002A 00733132646104 Lot Numbers: 31831566 31766110 31752926 31766113 31766108 31831567 31831569 31766115 31831564 31831565 Model Number / UDI-DI code: VBHR131002A 00733132646142 Lot Numbers: 31844911 31844913 31844914 31844916 31844922 31844917 31820789 31844919 31844912 31820790 31831663 31831664 Model Number / UDI-DI code: VBHR131002H 00733132651955 Lot Number: 31828735 Model Number / UDI-DI code: VBHR131002W 00733132644797 Lot Numbers: 31828718 31828717 31828719 31828720 Model Number / UDI-DI code: VBJR051002A 00733132623914 Lot Numbers: 31802822 31802821 31802827 31802820 31802823 31802826 31802824 31802818 Model Number / UDI-DI code: VBJR051502A 00733132623921 Lot Numbers: 31742391 31742392 31742393 31742394 31742390 31742395 Model Number / UDI-DI code: VBJR052502A 00733132623938 Lot Numbers: 31753593 31753596 31753594 31753595 Model Number / UDI-DI code: VBJR060702A 00733132624096 Lot Numbers: 31747775 31682473 31682479 31747776 31682475 31682476 31682480 31726170 31682474 31726167 31682477 31747777 31682478 31726166 31747774 31726169 31726171 Model Number / UDI-DI code: VBJR061502A 00733132623747 Lot Numbers: 31729956 31729957 31815491 31729946 31729954 31729960 31729955 31729950 31729951 31729958 31729952 31815492 31729948 31729959 31729945 31732530 31729947 31732531 31732532 31729949 Model Number / UDI-DI code: VBJR062502A 00733132623976 Lot Numbers: 31766195 31747773 31766191 31766192 31766225 31766220 31747756 31747762 31766218 31766226 31766197 31747757 31747755 31766223 31766190 31747764 31747758 31747767 31747765 31766202 31766203 31747759 31747763 31766221 31747761 31747772 31766219 31766193 31766224 31747771 31747766 31766198 31747754 31747768 31747769 31747770 Model Number / UDI-DI code: VBJR071002A 00733132623778 Lot Numbers: 31732851 31687507 31732846 31718036 31732852 31732847 31687503 31687504 31687501 31732848 31687510 31732849 31687502 31687505 31732835 31687506 31687509 31732854 31687508 31687511 Model Number / UDI-DI code: VBJR072502A 00733132623792 Lot Numbers: 31713035 31713041 31713040 31713042 31713036 31725945 31725938 31725939 31757523 31725942 31725940 31713037 31713044 31725941 31757522 31713039 Model Number / UDI-DI code: VBJR080502A 00733132623815 Lot Numbers: 31725819 31725820 Model Number / UDI-DI code: VBJR080702A 00733132624119 Lot Numbers: 31706824 31718137 31808025 31706828 31706825 31718128 31808028 31706829 31747554 31706830 31808027 31718119 31718121 31718136 31808026 31718131 31808023 31706832 31808024 31718132 31706831 31718127 31732552 31718135 31718133 31718123 31718125 31718129 31706852 31706853 31718130 Model Number / UDI-DI code: VBJR081002A 00733132623822 Lot Numbers: 31657868 31726064 31701883 31726060 31615834 31807953 31701882 31687933 31726032 31615830 31726066 31668958 31726061 31615829 31747616 31657869 31657863 31615832 31807954 31687915 31687916 31726033 31687912 31687913 31807956 31747614 31657859 31747618 31701887 31726063 31687914 31668959 31747617 31687917 31726065 31701885 31687910 31807955 31657862 31807957 31615833 31657870 31657861 31687934 31657867 31668960 31687911 31657860 31726067 31615831 31701886 31701884 Model Number / UDI-DI code: VBJR081502A 00733132623839 Lot Numbers: 31706875 31717918 31706872 31706877 31652771 31706874 Model Number / UDI-DI code: VBJR082502A 00733132623693 Lot Number: 31717732 Lot Code: Reference Attachment 7 Note to "Product Code" above - secondary product code of FPV, in addition to NPI Note to "Expected Life" below - The selected device lifetime used by Gore is limited to 1-10 years (depending on the indication) to meet regulatory requirements due to factors such as: " differing regulatory guidance and standards " post market clinical study follow-up time periods " disease progression " duration of clinical use " primary function of the endoprosthesis and endoprosthesis characteristics that deliver the function " indication/product literature assessment " mechanical integrity. The selected device lifetime as used by Gore to meet regulatory requirements is not meant to be a recommendation or indication for reintervention or removal of the endoprosthesis except as otherwise determined by the physician and/or per the applicable labeling. The selected device lifetime is not meant to be a warranty or guarantee as the actual duration of clinical use or implantation of the endoprosthesis for a particular patient may be shorter or longer than the selected device lifetime based on the patient s medical conditions, anatomy, or other medical treatment as well as procedure and clinical factors and decisions.
• FEI Number: 2017233
• Recalling Firm/ Manufacturer: W L Gore & Associates, Inc.; 1505 N 4th St; Flagstaff AZ 86004-5867
• For Additional Information Contact: 800-5288763
• Manufacturer Reason for Recall: Endovascular prosthesis were manufactured on equipment that was not operating with valid parameters and may cause the distal tip to separate.
• FDA Determined Cause: Process change control
• Action: On 09/03/2026, an "URGENT MEDICAL DEVICE RECALL/FIELD SAFETY NOTICE" was sent via UPS 2nd Day Air by a Third-Party Service (Sedgwick) to U.S. and Candian customers informing them that, Gore has identified through quality control testing that some VIABAHN devices were processed using equipment that was functioning outside of the validated range. This could potentially result in an incorrect bonding location of the distal tip onto the delivery catheter. To Healthcare providers: For patients already implanted with an affected device, Gore does not recommend prophylactic removal, reintervention, or additional monitoring solely as a result of this recall as the risk of surgical removal or reintervention are expected to outweigh the theoretical risks associated with this issue. Patient management should continue according to routine clinical care and the treating physician s judgment. Instructions for customers: 1. Discontinue the use of listed device(s). 2. Identify and return any unused devices within the scope of this recall for replacement. 3. Complete and sign the enclosed CUSTOMER RESPONSE FORM and return to WLGore6907@sedgwick.com within 2 weeks of receipt of this notification. 4. This notice needs to be shared with those who need to be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). Transfer this notice to other organization(s) on which this action has an impact (as appropriate). 5. If a listed device has been implanted, indicate the used device(s) on the CUSTOMER RESPONSE FORM and return to WLGore6907@sedgwick.com.
• Quantity in Commerce: 424
• Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NIP