GORE VIABAHN endoprosthesis recalled for possible tip separation
W L Gore & Associates is recalling certain GORE VIABAHN Endoprosthesis devices with Heparin or PROPATEN Bioactive Surface. The devices were made on equipment that was not operating with valid parameters, which may cause the distal tip to separate. The notice reports no injuries.
From the FDA notice · Read the official notice ↗ · All Gore recalls
What to do
- Set aside affected lots and do not use them; contact W L Gore & Associates for next steps.
- Check model numbers and lot numbers in the notice against your inventory. Examples include PAHR110502E and JHJR071002J.
- Patients who have received an affected device should contact their care team and the manufacturer; do not remove or stop the device on your own.
- The notice does not say how to get a replacement or repair; contact W L Gore & Associates.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 424
- Illnesses reported
- None reported
- Manufactured in
- 1505 N 4th St, Flagstaff, Arizona, United States
- Classification
- Class II
- Recall number
- Z-0360-2027
In the FDA's words
- Description
- 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 Endovascular prosthesis were manufactured on equipment that was not operating with valid parameters and may cause the distal tip to separate. 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 317048
- Hazard
- Endovascular prosthesis were manufactured on equipment that was not operating with valid parameters and may cause the distal tip to separate.
More from Gore
See all- Gore VIABIL Short Wire Biliary Endoprosthesis recalled for incorrect length labeling
ModerateFDAOct 21, 2026
- GORE VIABIL biliary endoprosthesis recalled over mislabeling
ModerateFDAAug 19, 2026