GORE VIABAHN VBX Balloon Expandable Endo BXAL082902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132637805), received between May 28, 2019 and Dec 7, 2022 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2022Device Stenosis; Device Stenosis

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS PLACED IN THE SUBCLAVIAN ARTERY FOR TREATMENT ON AN UNKNOWN ETIOLOGY. THE PATIENT DEVELOPED AN INFECTION, IN-STENT STENOSIS AND A MYCOTIC PSEUDOANEURYSM POST OPERATION. ON (B)(6) 2022, A THROMBECTOMY, ANGIOPLASTY AND A VBX DEVICE WERE IMPLANTED IN THE SUBCLAVIAN STENT FOR TREATMENT OF STENOSIS AND THE MYCOTIC PSEUDOANEURYSM. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR TREATMENT OF THE INFECTION. THE SECOND VBX DEVICE (IMPLANTED ON (B)(6) 2022) WAS ALSO FOLLOWED BY AN INFECTION AND TREATED WITH ANTIBIOTICS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 15936250 ↗
• MalfunctionSep 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF STENOTIC OCCLUSION IN THE LEFT SUBCLAVIAN ARTERY, AN 8MM X 29MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS TO BE IMPLANTED THROUGH A 7FR SLENDER SHEATH. WHEN THE DEVICE WAS ADVANCED TO THE LESION, THE PHYSICIAN MADE THE DECISION THAT THE DEVICE LENGTH WAS TOO SHORT. THE PHYSICIAN RETRACTED THE DEVICE AND MET RESISTANCE AT THE SHEATH, CONTINUED TO PULL AND THE DEVICE BECAME DISLODGED FROM THE CATHETER. THE PHYSICIAN USED A BALLOON CATHETER AND DEPLOYED THE DEVICE IN THE RADIAL ARTERY. A SECOND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (8MM X 59MM) WAS ADVANCED ACROSS THE LESION AND DEPLOYED SUCCESSFULLY. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9110931 ↗
• MalfunctionMay 28, 2019Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED WITH A LEFT SUBCLAVIAN LESION. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED THROUGH THE 7FR TUERMO SHEATH TO THE UN-DILATED LESION. WHEN THE DEVICE COULD BE ADVANCED NO MORE THE DOCTOR ELECTED TO REMOVE THE DEVICE. AS THE DOCTOR WAS WITHDRAWING THE DEVICE, HE WAS UNABLE TO GET IT INTO THE SHEATH. THE DEVICE 'POPPED' OFF THE CATHETER IN THE PATIENT. THE DOCTOR WAS ABLE TO SNARE THE DEVICE OUT OF THE PATIENT. THE PROCEDURE CONTINUED WITH THE DOCTOR PRE-DILATING THE LESION AND IMPLANTING ANOTHER GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8647440 ↗

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