GORE VIABAHN VBX Balloon Expandable Endo BXA102902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132637621), received between Jan 28, 2025 and Feb 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A BILATERAL COMMON ILIAC ARTERY STENTING PROCEDURE DURING WHICH A 10 MM × 29 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED. DURING THE PROCEDURE, THE VBX DEVICE REPORTEDLY DISLODGED FROM THE BALLOON CATHETER. THE REPORTER STATED THAT NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE; HOWEVER, A STEEP BIFURCATION WAS PRESENT, WHICH REPORTEDLY CAUSED THE SHEATH TO KINK. THE DELIVERY CATHETER REPORTEDLY REACHED THE INTENDED TREATMENT SITE. AT THAT TIME, THE DECISION WAS MADE TO USE A LONGER LENGTH ENDOPROSTHESIS, AND THE DELIVERY CATHETER WAS WITHDRAWN. UPON ATTEMPTED WITHDRAWAL OF THE DEVICE BACK INTO THE SHEATH, THE STENT REPORTEDLY COMPLETELY DISLODGED FROM THE BALLOON CATHETER. IT WAS SUSPECTED THAT THE STENT WAS PULLED OFF THE BALLOON BY CONTACT WITH THE SHEATH TIP DUE TO THE STEEP BIFURCATION. THE DISLODGED, UNDEPLOYED ENDOPROSTHESIS ULTIMATELY LODGED IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY. THE UNDEPLOYED ENDOPROSTHESIS WAS COMPRESSED AGAINST THE VESSEL WALL AND SUBSEQUENTLY STENTED OVER WITH A BARE METAL STENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT, AND THE PROCEDURE WAS CONSIDERED SUCCESSF

  Patient problems: Foreign Body In Patient

  MAUDE report 24292819 ↗
• MalfunctionJan 28, 2025Premature Separation; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE MESENTERIC ARTERY DURING A LASER FENESTRATION PROCEDURE OF AN AORTIC DISSECTION. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE VBX DEVICE THROUGH THE MEDTRONIC THORACIC STENT GRAFT INTO THE MESENTERIC ARTERY. AFTER A COUPLE ATTEMPTS THE PHYSICIAN DECIDED TO REMOVE THE VBX DEVICE THROUGH THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN). WITH NO ADDITIONAL FORCE THE DELIVERY SYSTEM WAS REMOVED, AND THE VBX DEVICE WAS OBSERVED TO HAVE DISLODGED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO USE A SNARE AND SUCCESSFULLY REMOVE THE VBX DEVICE. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL VBX DEVICE, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258011 ↗

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