GORE VIABAHN Endoprosthesis VBC101502Recalls & reported problems
W. L. Gore & Associates, Inc. · Class 3 · Implant
All models of GORE VIABAHN Endoprosthesis (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132614691), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (1 report).
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
Device problems
- Difficult or Delayed Activation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2020Difficult or Delayed Activation; Difficult or Delayed Activation
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, A PATIENT WAS TO BE IMPLANTED WITH A 10MM X 15CM GORE® VIABAHN® ENDOPROSTHESIS TO TREAT COMMON ILIAC ANEURYSM. IT WAS REPORTED THROMBOLYSIS WERE FIRSTLY PERFORMED. AFTER THAT THE COMMON ILIAC ARTERY WAS NOTED IN GOOD CONDITION WITHOUT TORTUOSITY AND CALCIFICATION. AFTER THE VIABAHN DEVICE WAS ADVANCED VIA 12FR SHEATH TO THE TARGET LESION, THE PHYSICIAN INITIATED THE DEPLOYMENT LINE, NO RESISTANCE WAS REPORTEDLY FELT. HOWEVER, THE DEPLOYMENT LINE GOT STUCK WHEN THE VIABAHN® DEVICE EXPANDED 1/3. THE VIABAHN® DEVICE COULDN'T BE DEPLOYED AFTER MANY ATTEMPTS. THE PHYSICIAN DECIDED TO WITHDRAW THE VIABAHN DEVICE BACK INTO THE SHEATH BUT COULDN'T MAKE IT. THEN THE VIABAHN DEVICE AND SHEATH WERE REMOVED IN TANDEM WITH GREAT EFFORTS. DURING THE REMOVAL, THE ENDOPROSTHESIS WAS TOTALLY EXPANDED AND DAMAGED. IT WAS DIFFICULT AND TOOK A LONG TO WITHDRAW THE VIABAHN DEVICE. A VBH111002W (11MM X 10CM), A VBC110502 (11MM X 5CM) AND A VBC100202(10MM X 5CM) WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9760771 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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