GORE VIABAHN VBX Balloon Expandable Endo BXBL087902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132658534), received between Sep 23, 2024 and Apr 14, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 6 most recent of 6 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 24875860 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR SURGERY TO TREAT STENOSIS IN THE ILIAC ARTERY WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). REPORTEDLY, THE VERY DISEASED VESSEL WAS PREDILATED WITH A 4MM BALLOON. THE PHYSICIAN THAN ATTEMPTED TO ADVANCE THE VBX DEVICE ACROSS THE STENOSIS OVER A 0.035" ABBOTT STEEL CORR GUIDE WIRE, THROUGH AN 8FR TERUMO INTRODUCER SHEATH. HOWEVER, THE VBX DEVICE WAS ONLY ABLE TO BE ADVANCED HALFWAY ACROSS THE LESION AND WOULD NOT FURTHER ADVANCE. THE PHYSICIAN ATTEMPTED TO REMOVE THE VBX DEVICE THROUGH THE INTRODUCER SHEATH WITH NO SUCCESS. THE ATTEMPTS TO MANIPULATE THE VBX DEVICE BACK INTO THE SHEATH AND PULLING THROUGH THE STENOSIS, DISPLACED THE STENT ON THE DELIVERY CATHETER TOWARDS THE DISTAL TIP. THE PHYSICIAN CONTINUED TO ATTEMPT THE REMOVAL THROUGH THE INTRODUCER SHEATH, CAUSING THE STENT TO BECOME DISLODGED IN THE GROIN. THE PHYSICIAN WAS ABLE TO REMOVE THE DISLODGED VBX DEVICE WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FOUR VBX DEVICES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007217 ↗
• InjuryDec 16, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE INFRARENAL AORTA FOR AORTOILIAC OCCLUSIVE DISEASE (AIOD) AND WAS IMPLANTED WITH AN AORTIC DEVICE AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 1 HOUR POST IMPLANT THE PATIENT BEGAN TO EXHIBIT SYMPTOMS AND THE PHYSICIAN DETERMINED ALL THREE DEVICES WERE OCCLUDED. THE PATIENT UNDERWENT A THROMBECTOMY AND IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED RHABDOMYOLYSIS. THE PATIENT TOLERATED THE PROCEDURE HOWEVER IT IS BELIEVED THAT THE PATIENT MAY REQUIRE AMPUTATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23818287 ↗
• InjuryOct 28, 2025Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A BILATERAL ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE WAS PERFORMED DUE TO INFRARENAL AORTIC ANEURYSM AND BILATERAL ILIAC ARTERY ANEURYSMS. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN THE RIGHT HYPOGASTRIC ARTERY. AN 8LMM X 79MM VBX DEVICE WAS IMPLANTED DISTALLY AND AN 11MM X 79MM VBX DEVICE IMPLANTED PROXIMALLY AND FLARED TO 14MM INSIDE THE IBE GATE WITH FULL 2.5CM OVERLAP. CONTRAST WAS OBSERVED OUTSIDE OF IBE AND INSIDE IIA ANEURYSM AT THIS TIME, WITH POSSIBLE TYPE III ENDOLEAK. THE PATIENT¿S HYPOGASTRIC ARTERY HAD A 360 DEGREE TURN AND IT WAS STRAIGHTENED WITH A STIFF GUIDEWIRE TO IMPLANT THE VBX DEVICES. ONCE THE STIFF GUIDEWIRE WAS REMOVED THE VESSEL TORTUOSITY RETURNED, POTENTIALLY DISCONNECTING THE VBX DEVICES. ON (B)(6) 2025, REVISION WAS FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE IMPLANTED VBX DEVICES IN THE HYPOGASTRIC ARTERY. ACCESS WAS GAINED FROM THE BRACHIAL ARTERY. A TYPE III ENDOLEAK BETWEEN THE TWO VBX DEVICES WAS CONFIRMED. THE PHYSICIAN CHOSE TO RELINE AND RECONNECT THE VBX DEVICES. AN 8FX90CM TERUMO DESTINATION SHEATH WAS USED TO ADVANCE THE FIRST VBX DEVICE (

  Patient problems: Clinical Endoleak

  MAUDE report 23410149 ↗
• MalfunctionAug 11, 2025Premature Separation; Premature Separation

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR INTERVENTION TARGETING THE LEFT INTERNAL ILIAC ARTERY. THE PROCEDURE UTILIZED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ACCESS WAS ESTABLISHED USING A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH, WITH AN 8FR COOK FLEXOR® ANSEL GUIDING SHEATH INSIDE OF THE 12FR. MULTIPLE GUIDEWIRES (MANUFACTURERS UNSPECIFIED) WERE EMPLOYED AND EXCHANGED AS NEEDED THROUGHOUT THE PROCEDURE. INITIALLY, THE PHYSICIAN WAS NOT ABLE TO REACH THE TARGET TREATMENT AREA AS THERE WAS AN UNKNOW OBSTRUCTION PASSAGE. EVENTUALLY THE PHYSICIAN WAS ABLE TO GET NEAR THE TARGET TREATMENT AREA BUT NOT EXACTLY, SO THE PHYSICIAN WANTED TO WITHDRAW THE VBX DEVICE, HOWEVER, BEFORE REACHING THE DISTAL END OF THE SHEATH, THE VBX DEVICE INADVERTENTLY DISLODGED FROM THE DELIVERY SYSTEM AND DEPLOYED NEAR THE TARGET TREATMENT ZONE WITH ACCEPTABLE PLACEMENT. MAINTAINING WIRE ACCESS, THE PHYSICIAN REMOVED THE VBX DELIVERY SYSTEM AND ADVANCED A 3¿4 MM BALLOON CATHETER INTO THE VBX ENDOPROSTHESIS. THE DEVICE WAS EXPANDED VIA MULTIPLE SHORT INFLATIONS. FOLLOWING STABILIZATION, THE VBX DEVICE BALLOON WAS USED FOR POST-DILATION TO THE NOMINAL DIAMETER PER TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779185 ↗
• MalfunctionSep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED TO TREAT AN ANEURYSM IN THE LEFT ILIAC ARTERY. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING A 12F GORE® DRYSEAL FLEX INTRODUCER SHEATH INSIDE AN 18F GORE® DRYSEAL FLEX INTRODUCER SHEATH OVER AN 0.035" GLIDEWIRE ADVANTAGE® GUIDEWIRES TO THE TARGET TREATMENT ZONE. IT WAS REPORTED, THE ENDOPROSTHESIS WAS TOO LONG AND THE DECISION WAS MADE TO WITHDRAWAL THE DELIVERY CATHETER FROM THE PATIENT. AN ATTEMPT TO PULL THE DELIVERY CATHETER BACK INTO THE SHEATH WAS MADE, DISLODGING THE STENT GRAFT IN THE ILIAC BIFURCATION. THE DEVICE WAS SUCCESSFULLY RETRIEVED USING A SNARE SYSTEM AND DISCARDED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287268 ↗

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