GORE VIABAHN VBX Balloon Expandable EndoRecalls & reported problems across all models
W. L. Gore & Associates, Inc. · 111 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one GORE VIABAHN VBX Balloon Expandable Endo model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 557
- Deaths reported
- 35
- Injuries reported
- 298
- Recalls
- 1
We found 111 models of GORE VIABAHN VBX Balloon Expandable Endo by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 557 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2017 and Sep 30, 2026 — classified as 35 deaths, 298 injuries, 223 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (82 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
GORE VIABAHN VBX Balloon Expandable Endo recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 1, 2024Open, Classified
Due to packaging defects, sterility assurance and heparin activity may be compromised.
Z-2945-2024 · Root cause: Package design/selection · names 60 of these models · Recall details · FDA record ↗
Most reported GORE VIABAHN VBX Balloon Expandable Endo problems
Device problems
- Detachment of Device or Device Component82
- Device Dislodged or Dislocated73
- Complete Blockage65
- Adverse Event Without Identified Device or Use Problem48
- Obstruction of Flow48
- Premature Separation42
- Partial Blockage26
- Device Endoleak20
Patient problems
- No Clinical Signs, Symptoms or Conditions170
- Thrombosis/Thrombus66
- Obstruction/Occlusion65
- Stenosis46
- Clinical Endoleak44
- Aneurysm23
- No Consequences Or Impact To Patient20
- Foreign Body In Patient18
GORE VIABAHN VBX Balloon Expandable Endo models
111 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- GORE VIABAHN VBX Balloon Expandable Endo BXB073902AIliac covered stent, arterial1 recall2 deaths19 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB057902AIliac covered stent, arterial1 recall2 deaths14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB067902AIliac covered stent, arterial1 recall14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB075902AIliac covered stent, arterial1 recall11 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB077902AIliac covered stent, arterial1 recall8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB085902AIliac covered stent, arterial1 recall2 deaths8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB095902AIliac covered stent, arterial1 recall8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB065902AIliac covered stent, arterial1 recall2 deaths7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB072902AIliac covered stent, arterial1 recall7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB097902AIliac covered stent, arterial1 recall7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXBL087902AIliac covered stent, arterial1 recall6 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB087902AIliac covered stent, arterial1 recall6 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB062902AIliac covered stent, arterial1 recall5 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB055902AIliac covered stent, arterial1 recall4 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB063902AIliac covered stent, arterial1 recall4 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB082902AIliac covered stent, arterial1 recall4 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB083902AIliac covered stent, arterial1 recall4 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB061902AIliac covered stent, arterial1 recall3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB062901AIliac covered stent, arterial1 recall3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB082901AIliac covered stent, arterial1 recall3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB087901AIliac covered stent, arterial1 recall3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB093902AIliac covered stent, arterial1 recall1 death3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB051902AIliac covered stent, arterial1 recall2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXBL085902AIliac covered stent, arterial1 recall2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXBL083902AIliac covered stent, arterial1 recall2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB072901AIliac covered stent, arterial1 recall2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB085901AIliac covered stent, arterial1 recall2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB052902AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXB065901AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXB071902AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXBL082902AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXB073901AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXB083901AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXB092902AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXB093901AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXB097901AIliac covered stent, arterial1 recall1 report
- GORE VIABAHN VBX Balloon Expandable Endo BXB051501AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB051502AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB051901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB052901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB053901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB053902AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB055901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB057901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB061501AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB061502AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB061901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB063901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB067901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB071501AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB071502AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB071901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXBL087901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXBL085901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXBL083901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXBL082901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB075901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB077901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB092901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXB095901AIliac covered stent, arterial1 recall0 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA115902AIliac Covered Stent, Arterial6 deaths31 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA077902AIliac Covered Stent, Arterial3 deaths27 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA067902AIliac Covered Stent, Arterial26 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA075902AIliac Covered Stent, Arterial1 death25 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA117902AIliac Covered Stent, Arterial1 death24 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA083902AIliac Covered Stent, Arterial17 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA095902AIliac Covered Stent, Arterial1 death17 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA085902AIliac Covered Stent, Arterial1 death15 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA057902AIliac Covered Stent, Arterial14 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA097902AIliac Covered Stent, Arterial1 death11 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXAL087902AIliac Covered Stent, Arterial11 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA115901AIliac Covered Stent, Arterial1 death11 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA073902AIliac Covered Stent, Arterial10 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA113902AIliac Covered Stent, Arterial2 deaths9 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA061902AIliac Covered Stent, Arterial8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA062902AIliac Covered Stent, Arterial8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA082902AIliac Covered Stent, Arterial8 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA065902AIliac Covered Stent, Arterial7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA093902AIliac Covered Stent, Arterial1 death7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA072902AIliac Covered Stent, Arterial7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXAL085902AIliac Covered Stent, Arterial1 death7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA117901AIliac Covered Stent, Arterial1 death7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXAL083902AIliac Covered Stent, Arterial1 death7 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA085901AIliac Covered Stent, Arterial2 deaths6 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA112902AIliac Covered Stent, Arterial6 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXAL085901AIliac Covered Stent, Arterial6 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA082901AIliac Covered Stent, Arterial2 deaths5 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA063902AIliac Covered Stent, Arterial4 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA083901AIliac Covered Stent, Arterial4 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA087902AIliac Covered Stent, Arterial4 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA052902AIliac Covered Stent, Arterial3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA072901AIliac Covered Stent, Arterial3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA107902AIliac Covered Stent, Arterial1 death3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXAL082902AIliac Covered Stent, Arterial3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXAL083901AIliac Covered Stent, Arterial3 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA055902AIliac Covered Stent, Arterial2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA065901AIliac Covered Stent, Arterial2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA075901AIliac Covered Stent, Arterial2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA093901AIliac Covered Stent, Arterial2 reports
- GORE VIABAHN VBX Balloon Expandable Endo BXA095901AIliac Covered Stent, Arterial2 reports
Recent GORE VIABAHN VBX Balloon Expandable Endo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Complete Blockage
Patient problems: Obstruction/Occlusion; Stenosis
MAUDE report 50955046 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 50937996 ↗InjurySep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937654 ↗InjurySep 28, 2026Partial Blockage; Complete Blockage
Patient problems: Insufficient Information; Obstruction/Occlusion; Restenosis
MAUDE report 50918245 ↗MalfunctionSep 1, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546865 ↗InjuryAug 12, 2026Deformation Due to Compressive Stress
The following was reported to Gore:On (b)(6) 2026, a patient underwent an endovascular procedure for abdominal aorta aneurysm treatment. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) was implanted. GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX devices) were implanted as branch devices in the visceral arteries.As reported, the physician stated a potential kink of the 6mm VBX device in right renal artery was noted post operatively. The patient experienced high blood pressure after the index procedure. This resolved after the patient's first bowel movement. On (b)(6) 2026, the VBX device kink was confirmed and reintervention was performed. The VBX device was relined with a 7mm x 30mm Protege Everflex stent. Result was resolution of the kink. The physician reportedly stated the cause of kink was external compression of the arcuate ligament.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50224083 ↗InjuryAug 11, 2026Insufficient Device Problem Information
Patient problems: Post Operative Wound Infection; Pseudoaneurysm
MAUDE report 50215233 ↗InjuryAug 6, 2026Partial Blockage
The following information was reported through the AAA 24-01 TAMBE Post Approval Study:On (b)(6) 2026, the patient underwent endovascular procedure to treat a thoracoabdominal aortic aneurysm using a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) device system and GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX device).During the index procedure, a suspected left kidney embolism was identified, which was then confirmed one day postop. Subsequently, the patient experienced left renal artery stent thrombosis, due to mural thrombus from the aneurysm embolizing the left renal artery. The patient was placed on anticoagulation therapy to prevent further thrombosis.FMAR code 2203 - other, used to capture thrombosis.
Patient problems: Obstruction/Occlusion
MAUDE report 50160800 ↗OtherAug 6, 2026Partial Blockage
The following information was reported through the AAA 24-01 TAMBE Post Approval Study:On (b)(6) 2026, the patient underwent endovascular procedure to treat a thoracoabdominal aortic aneurysm using a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) device system and GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX device).During the index procedure, a suspected left kidney embolism was identified, which was then confirmed one day postop. Subsequently, the patient experienced left renal artery stent thrombosis, due to mural thrombus from the aneurysm embolizing the left renal artery. The patient was placed on anticoagulation therapy to prevent further thrombosis.FMAR code 2203 - other, used to capture thrombosis.
Patient problems: Obstruction/Occlusion
MAUDE report 50159468 ↗InjuryJul 30, 2026Device Stenosis; Device Endoleak
On (b)(6) 2026, the patient underwent endovascular procedure to treat a thoracoabdominal aortic aneurysm using a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) device system. GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Device) devices were used in the visceral arteries. The patient tolerated the procedure. The Gore devices were successfully implanted.¿It was reported that on (b)(6) 2026, an Endoleak- indeterminate, but likely Type II was noted. On (b)(6) 2026 a CT (Computed Tomography) / CTA (Computed Tomography Angiography) was performed. It was noted there was a persistent indeterminate endoleak around the right renal artery, most consistent with a type 1c endoleak. The patient will require an angiogram with possible endovascular intervention.
Patient problems: Clinical Endoleak; Stenosis
MAUDE report 50092771 ↗InjuryJul 27, 2026Device Stenosis
On (b)(6) 2025, a patient underwent endovascular repair of a thoracoabdominal aortic aneurysm utilizing a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) system of components consisting of one aortic component, one thoracic component, one bifurcated component, one aortic extender, seven GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices, and three contralateral leg components. During the procedure, a VBX Device was delivered to the celiac trunk, navigated successfully to the intended location, deployed as intended, and implanted. Final completion angiography demonstrated that the device remained patent.On (b)(6) 2025, the patient was discharged.On (b)(6) 2026, the patient underwent computed tomography (CT) imaging follow-up. Evaluation demonstrated a patent aortic endograft and branch components with mild (<50%) stenosis of the celiac branch. No intervention or additional treatment was reported.
Patient problems: Stenosis
MAUDE report 50036827 ↗InjuryJul 22, 2026Device Endoleak
THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ON (B)(6) 2026, A TYPE 1C ENDOLEAK WAS IDENTIFIED IN THE CELIAC ARTERY. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED TO TREAT THE TYPE 1C ENDOLEAK BY EXTENDING WITH ANOTHER VBX DEVICE.
Patient problems: Clinical Endoleak
MAUDE report 25906527 ↗InjuryJul 22, 2026Device Endoleak
THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE TGR 2302AA STUDY AND THE IMEDIDATA DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND MULTIPLE VBX DEVICES IN THE EXTERNAL ILIAC ARTERIES. THE PROCEDURE WAS A SUCCESS AND NO ENDOLEAKS WERE OBSERVED AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6) 2026 A CT SCAN WAS PERFORMED WHICH IDENTIFIED A TYPE III ENDOLEAK. SEPARATION OF THE TRUNK-IPSI AND THE VBX ON THE LEFT SIDE WAS IDENTIFIED. THE EVENT IS ONGOING. ON (B)(6) 2026 A REINTERVENTION WAS PERFORMED AND AN 11MM X 79MM VBX DEVICE WAS PLACED TO TREAT THE TYPE III ENDOLEAK.
Patient problems: Clinical Endoleak
MAUDE report 25906359 ↗InjuryJul 15, 2026Complete Blockage
ON (B)(6) 2024, A PATIENT UNDERWENT A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES, MEASURING 7 MM X 59 MM, WERE IMPLANTED IN THE LEFT RENAL ARTERY. FOLLOWING THE INDEX PROCEDURE, THE PATIENT REPORTEDLY LEFT THE HOSPITAL AGAINST MEDICAL ADVICE (AMA) AND DID NOT TAKE PRESCRIBED PLAVIX (CLOPIDOGREL). ON (B)(6) 2024, THE PATIENT RETURNED WITH PAIN AND UNDERWENT A REINTERVENTION PROCEDURE. DURING THE PROCEDURE, A CLOT WAS IDENTIFIED WITHIN A LEFT RENAL ARTERY VBX DEVICE. ACCORDING TO THE PHYSICIAN, THE THROMBOTIC EVENT WAS BELIEVED TO BE ASSOCIATED WITH THE PATIENT'S FAILURE TO TAKE PRESCRIBED PLAVIX THERAPY. IT WAS NO STENOSIS PRESENT. THE AFFECTED LEFT RENAL ARTERY VBX DEVICE WAS RELINED WITH ADDITIONAL VBX DEVICE(S). THE PROCEDURE WAS REPORTEDLY WELL TOLERATED, AND THE REPORTER INDICATED THE INTERVENTION WAS SUCCESSFUL. THE LEFT RENAL ARTERY WAS REPORTED AS PATENT FOLLOWING TREATMENT, AND NO KNOWN RESIDUAL ADVERSE OUTCOMES WERE REPORTED AT THE TIME OF THE COMPLAINT.
Patient problems: Pain; Thrombosis/Thrombus
MAUDE report 25830533 ↗InjuryJul 9, 2026Complete Blockage
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE) IN CONJUNCTION WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). AT THE ONE-MONTH FOLLOW-UP VISIT, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2026, REVEALED OCCLUSION OF THE LEFT RENAL ARTERY EXTENDING TO THE PORTAL REGION. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A THROMBECTOMY USING A PENUMBRA CATHETER TO REMOVE THE THROMBUS. THE VBX DEVICE WAS THEN POST-DILATED WITH A 6 MM BALLOON. FOLLOWING THESE INTERVENTIONS, BLOOD FLOW TO THE KIDNEY WAS SUCCESSFULLY RESTORED.
Patient problems: Stenosis
MAUDE report 25766124 ↗
Other W. L. Gore & Associates, Inc. products
- GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
- GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
- GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
- GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
- GORE DUALMESH Biomaterial13 models · 485 reports
- GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
- GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports
- GORE TAG Conformable Thoracic Stent Graft25 models · 325 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page