GORE VIABAHN VBX Balloon Expandable Endo BXB097902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132658848), received between Oct 30, 2024 and May 1, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjuryMay 1, 2026Device Dislodged or Dislocated

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACOABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM, AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES IN THE BRANCH VESSELS. THE PATIENT TOLERATED THE PROCEDURE WITHOUT REPORTED COMPLICATIONS. ON (B)(6) 2026, A TYPE 1C ENDOLEAK WAS IDENTIFIED AT THE LEVEL OF THE SUPERIOR MESENTERIC ARTERY. ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION WITH PLACEMENT OF AN ADDITIONAL VBX DEVICE (9 MM × 59 MM) TO TREAT THE ENDOLEAK. THE REINTERVENTION SUCCESSFULLY RESOLVED THE EVENT, AND THE DEVICE WAS PATENT AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026.

  Patient problems: Clinical Endoleak

  MAUDE report 25057342 ↗
• InjuryMar 30, 2026Partial Blockage

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ON (B)(6) 2026, OCCLUSION WAS IDENTIFIED IN THE CELIAC ARTERY VBX DEVICE. NO REINTERVENTION HAS BEEN PERFORMED AT THIS TIME.

  Patient problems: Stenosis

  MAUDE report 24727712 ↗
• InjuryFeb 18, 2026Migration

  ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN EMERGENT THORACOABDOMINAL AORTIC RUPTURE USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES IN THE VISCERAL VESSELS. THE RENAL ARTERIES WERE PLUGGED USING ABBOTT AMPLATZER¿ VASCULAR PLUG II (AVP II). THE AVP II PLUGS WERE PLACED WITHIN THE VBX DEVICES. THE PROCEDURE CONCLUDED SUCCESSFULLY. ON AN UNKNOWN DATE, THE PATIENT BECAME HYPOTENSIVE POST OPERATION. IT WAS DETERMINED THE VBX DEVICE HAD MOVED FROM THE SUPERIOR MESENTERIC ARTERY (SMA) PORTAL OF THE TAMBE DEVICE, FORMING A POST-PROCEDURE TYPE III EDNOLEAK. IT'S UNKNOWN WHY THE VBX DEVICE MOVED. A REINTERVENTION TOOK PLACE TO RELINE THE SMA PORTAL. TWO DAYS POST OPERATION, THE PATIENT EXPIRED, DUE TO THE PATIENT'S FAMILY DECIDED TO DISCONTINUE CARE. ACCORDING TO THE PHYSICIAN, THE PATIENT HAD GI BLEEDING. THE PATIENT HAD MALPERFUSION TO SOME OF THEIR VISCERAL VESSELS AND IT WAS NOT UNEXPECTED THAT THE PATIENT HAD GI BLEEDING. THE PHYSICIAN DID NOT STATE THAT GORE DEVICES CAUSED OR CONTRIBUTED TO THE MALPERFUSION - THE PATIENT DIDN¿T HAVE BLOOD FLOW TO BEGIN WITH. THE MALPERFUSION O

  Patient problems: Clinical Endoleak

  MAUDE report 24380748 ↗
• InjuryNov 4, 2025Patient-Device Incompatibility; Device Endoleak; Patient-Device Incompatibility; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE (B)(6) TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A PARARENAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES). THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS DONE AND AN AORTIC ANEURYSM ENLARGEMENT OF 10MM WAS DETERMINED. ADDITIONALLY, ON (B)(6) 2025, AN ENDOLEAK OF AN UNKNOWN ETIOLOGY WAS DETERMINED. ACCORDING TO DR. (B)(6) THE ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT. THE SITE UPDATED THE STUDY DATA FOR: ON OCTOBER 11, 2025, A TYPE II ENDOLEAK AND A TYPE IIIC ENDOLEAK WERE DETERMINED. THE PATIENT RECEIVED VASOACTIVE MEDICATIONS PENDING VASCULAR SURGERY CONSULT. ON (B)(6) 2025, THE ADDITIONAL PROCEDURE WAS DONE WHERE DR. (B)(6) DID THE FOLLOWING: STENTED THE SUPERIOR MESENTERIC AND RIGHT RENAL ARTERIES AS WELL AS RETROGRAFTED THE AORTIC SAC ACCESS WITH A STENTING OF RIGHT RENAL WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE AND DID A COIL EMBOLIZAT

  Patient problems: Clinical Endoleak

  MAUDE report 23466752 ↗
• InjuryMay 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT WAS TREATED USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICE) DEVICES IN THE BRANCH VESSELS. IT WAS REPORTED DURING THE PROCEDURE, TWO 9 MM X 79 MM VBX DEVICES WERE IMPLANTED WITHOUT INCIDENCE IN THE SUPERIOR MESENTERIC ARTERY (SMA). AT THE END OF THE PROCEDURE THERE WERE NO ENDOLEAKS NOTED, AND THE SMA WAS PATENT. ON AN UNKNOWN DATE, A COUPLE OF DAYS LATER, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A ENDOLEAK BETWEEN THE TWO VBX DEVICES. THE PROXIMAL VBX DEVICE WAS STILL POSITIONED IN THE TAMBE PORTAL AND THE DISTAL VBX DEVICE WAS IN THE SMA. HOWEVER, IT WAS REPORTED THERE WAS A GAP BETWEEN THE TWO DEVICES. ON (B)(6) 2025, THERE WAS A REINTERVENTION PROCEDURE PERFORMED TO EXCLUDE THE ENDOLEAK. ANOTHER VBX DEVICE WAS IMPLANTED, BRIDGING THE PREVIOUSLY PLACED DEVICES. IT WAS REPORTED THE SMA WAS PATENT THROUGHOUT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22004498 ↗
• InjuryMay 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT WAS TREATED USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICE) DEVICES IN THE BRANCH VESSELS. IT WAS REPORTED DURING THE PROCEDURE, TWO 9 MM X 79 MM VBX DEVICES WERE IMPLANTED WITHOUT INCIDENCE IN THE SUPERIOR MESENTERIC ARTERY (SMA). AT THE END OF THE PROCEDURE THERE WERE NO ENDOLEAKS NOTED, AND THE SMA WAS PATENT. ON AN UNKNOWN DATE, A COUPLE OF DAYS LATER, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED AN ENDOLEAK BETWEEN THE TWO VBX DEVICES. THE PROXIMAL VBX DEVICE WAS STILL POSITIONED IN THE TAMBE PORTAL AND THE DISTAL VBX DEVICE WAS IN THE SMA. HOWEVER, IT WAS REPORTED THERE WAS A GAP BETWEEN THE TWO DEVICES. ON (B)(6) 2025, THERE WAS A REINTERVENTION PROCEDURE PERFORMED TO EXCLUDE THE ENDOLEAK. ANOTHER VBX DEVICE WAS IMPLANTED, BRIDGING THE PREVIOUSLY PLACED DEVICES. IT WAS REPORTED THE SMA WAS PATENT THROUGHOUT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22003975 ↗
• MalfunctionOct 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR IMPLANTATION INTO THE LEFT HYPOGASTRIC ARTERY AS AN EXTENSION TO A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) IN AN ENDOVASCULAR PROCEDURE TO REPAIR ANEURYSMS. CONTRALATERAL ACCESS WAS GAINED, AND IT WAS REPORTED THAT THERE WAS AN INABILITY TO ADVANCE THE VBX DEVICE DELIVERY CATHETER (DUE TO EXCESSIVELY TORTUOUS ANATOMY) THROUGH A 12 F GORE® DRYSEAL FLEX INTRODUCER SHEATH. REPORTEDLY, DURING REMOVAL, THE VBX DEVICE DELIVERY CATHETER BROKE AT THE HUB AND THE STENT PORTION DISLODGED FROM THE BALLOON AND INTO THE LEFT COMMON ILIAC ARTERY (LCIA). THE VBX DEVICE STENT PORTION WAS LEFT IN THE LCIA AS ENDOTRASH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20566572 ↗

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