GORE VIABAHN VBX Balloon Expandable Endo BXB082901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132658695), received between Jun 4, 2024 and Apr 14, 2026 — classified as 3 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 1, 2024Class IIOpen, Classified

   Due to packaging defects, sterility assurance and heparin activity may be compromised.

   Z-2945-2024 · Root cause: Package design/selection · Recall details · FDA record ↗

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.

• MalfunctionApr 14, 2026Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF OCCLUSION WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) IN THE RIGHT AND LEFT ILIAC ARTERIES DURING A KISSING STENT PROCEDURE. REPORTEDLY, DURING THE ADVANCEMENT OF THE 8MM X 79MM VBX DEVICE INTO THE RIGHT ILIAC, THE TECHNICIAN LOST WIRE ACCESS AND THE PHYSICIAN ATTEMPTED TO REMOVE THE VBX DEVICE BACK THROUGH THE 8FRX11CM CORDIS BRIGHT TIP INTRODUCER SHEATH AND THE DEVICE BECAME DISLODGED. THE PHYSICIAN ADVANCED A MUSTANG BALLOON THROUGH THE VBX DEVICE AND DEPLOYED IT IN THE RIGHT COMMON ILIAC ARTERY JUST BELOW THE HYPOGASTRIC ARTERY. THE PHYSICIAN THEN ADVANCED A NEW VBX DEVICE AND GOT IT INTO POSITION IN THE RIGHT ILIAC AND ADVANCED A 8MM X 29MM INTO THE LEFT ILIAC, IN THE KISSING STENT CONFIGURATION. HE THEN MADE THE DECISION THAT HE WANTED AN 8MM X 39MM VBX DEVICE AND ATTEMPTED TO REMOVE THE VBX DEVICE THROUGH THE 8FRX11CM CORDIS BRIGHT TIP INTRODUCER SHEATH, AND THE SECOND DEVICE BECAME DISLODGED. THE PHYSICIAN ADVANCED A MUSTANG BALLOON THROUGH THE VBX DEVICE AND DEPLOYED IT IN THE COMMON LEFT ILIAC ARTERY JUST BELOW THE HYPOGASTRIC ARTERY. THE PROCEDURE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875572 ↗
• MalfunctionJun 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFTS) WERE IMPLANTED IN THE RENAL ARTERY, SUPERIOR MESENTERIC ARTERY (SMA), AND THE CELIAC ARTERY WITH A COOK FENESTRATED AORTIC GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) USING THE PHYSICIAN MODIFIED ENDOGRAFT (PMEG) TECHNIQUE. THE VBX STENT GRAFTS WERE IMPLANTED INTO THE RENAL ARTERY AND SMA WITHOUT DIFFICULTY. REPORTEDLY, THE PROCEDURE PRESENTED A CHALLENGE FOR THE PHYSICIAN WITH THE APPROACHED ANGLE ACCESSED FROM THE BRACHIAL ARTERY; THROUGH A COOK FENESTRATED AORTIC GRAFT; TO THE IMPLANT SITE OF THE CELIAC ARTERY. THE VBX STENT GRAFT WAS ADVANCED OVER A 0.035¿ COOK ROSENWIRE THROUGH A 7.5 F TOURGUIDE STEERABLE SHEATH WITHOUT DIFFICULTY. FIRST WITH THE INTRODUCER SHEATH A QUARTER OF THE WAY INTO THE CELIAC ARTERY THE VESSEL WAS BALLOONED. IT WAS NOTED, THE PHYSICIAN WITHDREW THE VBX DEVICE DELIVERY CATHETER SLIGHTLY INTO THE INTRODUCER SHEATH AND AT THAT TIME THE VBX STENT GRAFT DISLODGED IN THE VESSEL OFF OF THE CATHETER. THE PHYSICIAN REPORTEDLY REMOVED THE VBX DEVICE DELIVERY CATHETER WITHOUT DIFFICULTY AND WAS ABLE TO SNARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532747 ↗
• MalfunctionJun 4, 2024Break; Difficult to Remove; Break; Difficult to Remove

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024 A REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED INTO THE CELIAC ARTERY IN A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) PROCEDURE. ACCESS WAS GAINED IN THE PATIENT THROUGH THE FEMORAL ARTERY. THE VBX STENT GRAFT WAS IMPLANTED SUCCESSFULLY OVER A 0.035" GUIDEWIRE AND THROUGH A 7 F TERUMO INTRODUCER SHEATH. IT WAS REPORTED THAT THE BALLOON ON THE VBX DEVICE DELIVERY CATHETER WAS DEFLATED PRIOR TO ATTEMPTED REMOVAL. HOWEVER, THERE WAS DIFFICULTY WITH WITHDRAWAL OF VBX DEVICE DELIVERY CATHETER INTO INTRODUCER SHEATH. CONSEQUENTLY, THE VBX DEVICE DELIVERY CATHETER BROKE WHEN THE PHYSICIAN PULLED BACK AGAIN WITH FORCE TO WITHDRAW IT INTO THE INTRODUCER SHEATH. ULTIMATELY, THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN VBX DEVICE DELIVERY CATHETER WITHIN THE INTRODUCER SHEATH WITH NOTHING LEFT INSIDE THE PATIENT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459987 ↗

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