GORE VIABAHN VBX Balloon Expandable Endo BXB082902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132658701), received between May 17, 2024 and Jan 8, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Detachment of Device or Device Component; Activation Failure; Difficult or Delayed Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR SURGERY IN THE LEFT COMMON ILIAC ARTERY DURING TREATMENT OF STENOSIS WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). REPORTEDLY, THE VSX DEVICE WAS DELIVERED THROUGH AN 8FR DESTINATION SHEATH THAT WAS PARKED IN RIGHT COMMON ILIAC ARTERY / STENT WAS DELIVERED BARE BACK OVER 0.035" AMPLATZ GUIDE WIRE UP AND OVER BIFURCATION TO DESIRED LOCATION. BALLOON WAS INFLATED TO NOMINAL PRESSURE HOWEVER, ONLY DOG BONING OF BALLOON WAS VISUALIZED ON BOTH ENDS. BALLOON WAS DEFLATED SLOWLY HOWEVER DOG BONING OF BALLOON REMAINED UNCHANGED. BALLOON WAS AGAIN INFLATED UP TO NOMINAL PRESSURE WITH NO CHANGE. BALLOON WAS THEN INFLATED UP TO 20 ATM, STILL NO VISUAL CHANGE. BALLOON WAS STILL DOG BONED WITH ENDS OF STENT INFLATED SLIGHTLY AND MIDDLE OF STENT NOT INFLATED AT ALL. BALLOON WAS AGAIN DEFLATED SLOWLY WITH NO DEFLATION OF DOG BONED BALLOON. A 20 CC SYRINGE WAS USED TO DRAW NEGATIVE SEVERAL TIMES BUT STILL NO DEFLATION OF BALLOON AT ENDS OF STENT. AT THIS POINT, STENT CATHETER COULD NOT BE ADVANCED OR RETRACTED WITH GENTLY PULLING AND THE GUIDE WIRE COULD ALSO NOT BE ADVANC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006875 ↗
• MalfunctionNov 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: DURING A AAA PROCEDURE USING A PHYSICIAN MODIFIED GRAFT (UNKNOWN MANUFACTURER), A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS TO BE IMPLANTED FOR REPERFUSION OF THE SUPERIOR MESENTERIC ARTERY (SMA). ACCESS WAS MADE FROM THE COMMON FEMORAL ARTERY. USING A 7.5FR APTUS STEERABLE SHEATH, THE VBX DEVICE WAS ADVANCED INTO THE OSTIUM OF THE SMA. AS THE SHEATH WAS PULLED BACK, THE VBX STENT FLICKED OUT OF THE SMA AND THE VBX STENT WAS DISLODGED INSIDE THE SHEATH. THE PHYSICIAN WAS ABLE TO PULL THE SHEATH AND CATHETER BACK. THE DISLODGED VBX STENT WAS THEN REMOVED BY HAND WITH NO ISSUES. A NEW, SAME SIZED VBX DEVICE WAS ADVANCED AND DEPLOYED WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619780 ↗
• MalfunctionOct 4, 2024Break; Activation Failure; Premature Separation; Break; Activation Failure; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, UNDERWENT A THORACOABDOMINAL ENDOGRAFT PROCEDURE WHERE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE(S)) WERE IMPLANTED IN THE COMMON ILIAC ARTERIES (CIA). IT WAS REPORTED THE PHYSICIAN WAS ABLE TO GET BOTH VBX DEVICES TO THE TARGET TREATMENT AREA WHERE THE 8X39 VBX DEVICE WAS IN THE LEFT CIA AND 8X29 WAS IN THE RIGHT CIA. THE VBX DEVICES WENT THROUGH 7FR TERUMO PINNACLE® INTRODUCER SHEATH AND OVER CORDIS .035" STORQ¿ GUIDEWIRE. BOTH VBX DEVICES WERE BEING INFLATED SIMULTANEOUSLY TO NOMINAL PRESSURE VIA KISSING STENT TECHNIQUE. THE VBX ON THE LEFT CIA INFLATED WITH NO ISSUE. THE VBX DEVICE ON THE RIGHT SIDE INFLATED ON THE PROXIMAL AND DISTAL END OF THE STENT, BUT THE MIDDLE WAS LEFT UNINFLATED. AS THEY ATTEMPTED TO GO HIGHER IN PRESSURE, TO GET THE STENT TO FULLY INFLATE, THE BALLOON APPEARED TO HAVE RUPTURED. THEY ATTEMPTED TO REMOVE THE BALLOON, HOWEVER, THERE WAS RESISTANCE. THEY WERE FINALLY ABLE TO REMOVE THE BALLOON, BUT IT DISLODGED THE STENT AS THEY PULLED IT BACK. THEY WERE ABLE TO ADVANCE A FRESH 8X40 PTA BALLOON THROUGH THE STENT AND WERE ABLE TO EXPAND THE STENT. THEY DID HOWEVER HAVE TO IMPLANT AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372695 ↗
• InjuryMay 17, 2024Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2024, THE PATIENT UNDERWENT TREATMENT FOR A CELIAC ANEURYSM WHERE A TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED. THE PROCEDURE WAS SUCCESSFUL WITH GOOD OVERLAP BETWEEN THE TWO VBX DEVICES. THEY PLACED A 6X29 AND EXTENDED WITH AN 8X29 VBX DEVICE. THE PATIENT HAD A GOOD OUTCOME. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SOME PAIN IN THE ABDOMEN AND IN THE PELVIC. ON (B)(6), 2024 THE PHYSICIAN WENT TO EXTEND THE VBX DEVICES MORE AND IT WAS NOTICED THAT THE 8X29 VBX DEVICE MIGRATED INTO THE LEFT COMMON ILIAC. THE PHYSICIAN CONFIRMED THAT THE VBX DEVICE WAS STILL OPEN AND A DISTAL PULSE WAS FELT. THE PHYSICIAN LEFT IT AS ENDOTRASH. IT WAS REPORTED THAT THE PHYSICIAN PLACED A NEW VBX DEVICE TO REPLACE THE ORIGINAL 8X29 VBX DEVICE IN THE CELIAC ARTERY. THE PROCEDURE WAS CONCLUDED WITHOUT ANY OTHER REPORTED ISSUE AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Abdominal Pain; Pelvic Pain

  MAUDE report 19347487 ↗

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