GORE VIABAHN VBX Balloon Expandable Endo BXA072901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132637508), received between Dec 13, 2022 and Nov 1, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

1 other recall cover devices cleared under the same FDA submission (P160021); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Break; Activation Failure; Break; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT TREATMENT FOR AN ILIAC ANEURYSM WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED IN THE HYPOGASTRIC ARTERY. THIS WAS A COOK MEDICAL IBG BRANCHED GRAFT CASE. IT WAS REPORTED THE PHYSICIAN HAD ACCESS SITE OF THE FEMORAL ARTERY WHERE THE VIABAHN DEVICE REACHED THE TARGET TREATMENT AREA WITHOUT ANY ISSUES USING A COOKMEDICAL INTRODUCER SHEATH (UNKNOWN SIZE) WITH AN UNKNOWN GUIDEWIRE. THE TARGET TREATMENT AREA WAS NOT PRE-TREATED BY PRE-DILATION/BALLOONING. THE PHYSICIAN WENT TO INITIATE DEPLOYMENT BY PULLING ON THE DEPLOYMENT LINE OF THE VIABAHN DEVICE WHEN THEY NOTICED NO INITIATION OF DEPLOYMENT. THE PHYSICIAN PULLED ON THE DEPLOYMENT LINE WITH SOME FORCE AND THE DEPLOYMENT LINE BROKE. THE VIABAHN DEVICE WAS WITHDRAWN FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT SIZE VIABAHN DEVICE. THE VIABAHN DEVICE REMAINED FULLY CONSTRAINED AFTER BEING WITHDRAWN FROM THE PATIENT. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592701 ↗
• MalfunctionDec 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED FOR TREATMENT DUE TO A BLEED FROM THE CELIAC TRUNK. INITIAL ACCESS WAS GAINED FROM THE COMMON FEMORAL ARTERY. A 7 X 45 FLEXOR® ANSEL GUIDING SHEATH WAS USED TO ADVANCE A 7 X 29 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (DEVICE/STENT) OVER AN ADVANTAGE GUIDEWIRE INTO THE CELIAC TRUNK. AT THIS TIME IT WAS REALIZED THE DEVICE WAS TOO LONG FOR THE CELIAC ARTERY AND WOULD LIKELY EXCLUDE MAJOR BRANCHES. THE PHYSICIAN ELECTED TO REMOVE THE DEVICE AND UTILIZE A SHORTER DEVICE. IN ORDER TO RECAPTURE THE DEVICE AFTER IT WAS FULLY INTRODUCED INTO THE VESSEL, THE PHYSICIAN DECIDED TO ADVANCE THE SHEATH FURTHER. HOWEVER, THE STENT WAS DISLODGED FROM THE CATHETER AS IT CAME IN CONTACT WITH THE SHEATH EDGE. THE DISLODGED STENT THAT WAS STILL ON THE GUIDEWIRE WAS LEFT IN THE SPLENIC ARTERY. A NEW 7 X 29 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED AND DEPLOYED FROM THE ORIGIN OF THE CELIAC TO THE COMMON HEPATIC ARTERY. THE BLEEDING WAS RESOLVED AND THE PATIENT IS REPORTED TO BE RECOVERING WELL FOLLOWING THIS PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16069815 ↗
• MalfunctionDec 13, 2022Material Rupture; Material Rupture

  ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT FOR AN AORTIC ANEURYSM REPAIR IN THE RENAL ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AS A PART OF A FENESTRATED ENDOGRAFT. THE PHYSICIAN STATED THE FENESTRATED MAIN BODY WAS A MODIFIED COOK ENDOGRAFT. THE VBX DEVICE WAS ADVANCED OVER A ROSEN WIRE THROUGH A TOURGUIDE SHEATH INTO THE RENAL ARTERY. DURING INFLATION OF THE VBX DEVICE IT WAS REPORTED THE BALLOON LOST ITS UNIFORM SHAPE. THE DISTAL END DEFLATED AND THE PROXIMAL END ENLARGED. THE BALLOON WAS DEFLATED AND WITHDRAWN FROM THE PATIENT. IT WAS REPORTED THE ENDOPROSTHESIS WAS FULLY DEPLOYED. HOWEVER, UPON FINAL IMAGING IT WAS IDENTIFIED THAT THE ENDOPROSTHESIS MOVED FURTHER INTO THE RENAL ARTERY. AN ADDITIONAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED TO BRIDGE THE VBX DEVICE IN THE RENAL ARTERY TO THE FENESTRATED ENDOGRAFT SYSTEM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973745 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160021. One submission often covers many models, so check the product and lot details in each record.

• Z-0077-2022 · Sep 7, 2021 · Open, Classified
  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 Diame