GORE VIABAHN VBX Balloon Expandable Endo BXB072902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132658626), received between Jul 16, 2024 and Nov 4, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE SUPERIOR MESENTERIC ARTERY (SMA) DURING TREATMENT ON STENOSIS. AFTER THE 6FR TOURGUIDE¿ STEERABLE SHEATH WAS ADVANCED INTO THE SMA, THE PHYSICIAN PULLED BACK THE SHEATH AND ATTEMPTED TO POSITION THE VBX DEVICE AND FELT IT GET CAUGHT ON SOME CALCIFICATION AT THE OSTIUM. AFTER AN ANGIOGRAM WAS PERFORMED THE VBX DEVICE WAS OBSERVED TO HAVE DISLODGED AND PULLED INTO THE AORTA. THE PHYSICIAN REMOVED THE DEVICE WITH A SNARE AND DECIDED TO NOT TREAT THE SMA DUE TO NOT HAVING ANOTHER 7 MM X 29 MM VBX DEVICE AVAILABLE. DURING CLOSURE, THE PATIENT WAS LOSING A LOT OF BLOOD, DUE TO THE CLOSURE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466401 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DISLODGED FROM THE BALLOON. THE PHYSICIAN USED A SNARE TO REMOVE THE DEVICE. DETAILS WERE REQUESTED BUT WAS NOT PROVIDED AS OF TODAY.

  Patient problems: Insufficient Information

  MAUDE report 23408881 ↗
• InjurySep 8, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR AN AORTIC DISSECTION, DURING WHICH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED IN THE RENAL ARTERY. ON (B)(6) 2025, IT WAS REPORTED THAT THE VBX DEVICE HAD DISLODGED FROM THE RENAL ARTERY AND MIGRATED TO THE COMMON FEMORAL ARTERY. THE DEVICE WAS SUCCESSFULLY REMOVED VIA OPEN SURGICAL EXTRACTION. NO REPLACEMENT VBX DEVICE WAS IMPLANTED. IT WAS REPORTED THE VBX DEVICE WAS NOT OVERLAPPING ANOTHER DEVICE AT THE TIME OF INITIAL PLACEMENT. IT IS UNKNOWN WHETHER A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED OR IF THE DEVICE WAS POST-DILATED. THE DEVICE WAS DEPLOYED IN THE CORRECT LOCATION. THERE WERE NO CONFIRMED INSTANCES OF TRAUMA OR SUDDEN MOVEMENT. THE AORTIC DISSECTION WAS TREATED WITH A GORE STENT GRAFT. THE PHYSICIAN SPECULATED THAT THE SEPTUM ASSOCIATED WITH THE AORTIC DISSECTION MAY HAVE CONTRIBUTED TO THE DEVICE DISLODGEMENT AND MIGRATION. THE PATIENT IS CURRENTLY STABLE AND RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22997916 ↗
• MalfunctionNov 15, 2024Separation Failure; Separation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 7 MM X 29 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE SUPERIOR MESENTERIC ARTERY (SMA) DURING TREATMENT OF STENOSIS. AFTER PRE-DILATING THE SMA WITH A 4 MM BALLOON, THE PHYSICIAN ADVANCED A VBX DEVICE OVER AN 0.035" GLIDE ADVANTAGE GUIDE WIRE THROUGH AN OSCAR STEERABLE INTRODUCER SHEATH (SIZE UNKNOWN). HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE VBX DEVICE THOUGH THE VESSEL STENOSIS. DURING THE REMOVAL OF THE VBX DEVICE THROUGH THE INTRODUCER SHEATH, THE DEVICE GOT HUNG UP ON THE EDGE OF THE SHEATH AND BECAME DISLODGED. THE PHYSICIAN WAS ABLE TO PULL THE VBX DEVICE INTO THE COMMON ILIAC ARTERY AND PIN IT TO THE WALL WITH AN ADDITIONAL VBX DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 6 MM X 29 MM VBX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698808 ↗
• MalfunctionNov 15, 2024Premature Activation; Premature Activation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT TREATMENT FOR A PREVIOUSLY PLACED PMEG COOK AAA STENT GRAFT WHERE IT HAD AN ANEURYSM THAT LEAD TO AN ENDOLEAK IN THE AORTA, ADVANCING INTO THE LEFT RENAL. A REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED. IT WAS REPORTED THE PHYSICIAN DID NOT REACH THE TARGET TREATMENT AREA AS THE VBX CATHETER WOULD NOT CROSS INTO THE LEFT RENAL ARTERY. A COOKMEDICAL 6 FR ANSEL SHEATH AND COOKMEDICAL ROSEN GUIDEWIRE WERE USED WITH AN ACCESS SITE OF THE RIGHT GROIN. THE PHYSICIAN FELT THE VBX DEVICE GOT CAUGHT ON SOMETHING WHILE ATTEMPTING TO ADVANCE, A POP FORWARD OF THE VBX DEVICE. THEY NOTICED THE COOK STENT GRAFT WAS IN THE WAY AND IT NEEDED TO BE BALLOONED A BIT TO OPEN IT UP. THE VBX DEVICE WAS REMOVED AND BALLOONED THE ORIFICE OF THE LEFT RENAL. AT THIS TIME, THE VBX CATHETER DID NOT APPEAR TO BE DAMAGED SO THE PHYSICIAN REINTRODUCED THE VBX DEVICE BACK INTO THE PATIENT. WHEN ADVANCING THE VBX DEVICE, THEY CAME ACROSS SOME RESISTANCE, SOME FORCE WAS USED WHILE ATTEMPTING TO ADVANCE THE VBX DEVICE. THE VBX DEVICE DISLODGED FROM THE CATHETER WHEN ADVANCING INTO THE RENAL. THE PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20697078 ↗
• InjurySep 19, 2024Premature Separation; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON SEPTEMBER 3, 2024, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE RIGHT SUBCLAVIAN ARTERY DURING TREATMENT OF STENOSIS. A 6FR TERUMO R2P SLENDER SHEATH WITH A GLIDEWIRE ADVANTAGE WIRE WERE ADVANCED BEYOND THE LESION AND THE STENT WAS ADVANCED INTO POSITION. THE PHYSICIAN THEN REALIZED THE TAKEOFF OF THE RIGHT COMMON CAROTID ARTERY WAS TOO CLOSE TO LAND THE STENT. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SHEATH BACK OVER THE STENT IN ORDER TO RETRACT THE VBX DEVICE AND REALIZED IT HAD BECOME DISLODGED FROM THE BALLOON. THE PHYSICIAN WAS THEN ABLE TO GET A 3MM BALLOON BALLON (MANUFACTURER UNKNOWN) IN THE STENT AND MOVE IT INTO THE UPPER ARM. THE PATENT WAS THEN TAKEN TO THE OR TO HAVE THE STENT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263701 ↗
• MalfunctionJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  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 ILIAC ARTERY DURING TREATMENT OF STENOSIS. AS REPORTED, THE VBX DEVICE REACHED THE INTENDED TREATMENT SITE, AND WAS SUCCESSFULLY DELIVERED WITH NO ISSUES. HOWEVER, WHEN THE VBX BALLOON CATHETER WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THE BALLOON COVERING HAD BECOME DETACHED ON THE PROXIMAL END. THE REMOVED BALLOON WAS CONFIRMED TO HAVE NO MISSING PIECES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. 2203-A:-OTHER (BALLOON COVER DETACHED DURING CATHETER WITHDRAWAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756561 ↗

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