GORE VIABAHN Endoprosthesis VBCR070502ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO 35 RO 7mmX5cm 8Fr 120cmCath · 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 00733132623440), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Entrapment of Device; Device-Device Incompatibility
THE FOLLOWING WAS REPORTED TO GORE: A PATIENT PRESENTED FOR TREATMENT OF AN IN-STENT EDGE STENOSIS IN THE PATIENT'S ARM. AS REPORTED, THERE WAS A PRE-EXISTING GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE). IMPLANT DATE OF PRE-EXISTING VIABAHN® STENT IS UNKNOWN. DURING AN A-V CIRCUIT INTERVENTION, THE TARGET LESION WAS NOT PRE-DILATED. A 7MM X 5CM VIABAHN® DEVICE WAS DEPLOYED . ON IMAGING, THE EXPANDED VIABAHN® STENT END APPEARED TO BE BUNCHED. THE VIABAHN® STENT WAS POST-DILATED, WHICH FURTHER IMPROVED THE BLOOD FLOW. AS REPORTED, A SMALL SECTION OF THE STENOTIC LESION WAS NOT COVERED, AND THE COMPRESSED AREA WAS STILL PRESENT AT THE END OF THE PROCEDURE. THE PHYSICIAN CHOSE A 'WAIT AND SEE' APPROACH. THE PATIENT TOLERATED THE PROCEDURE AND WAS REPORTED TO BE RECOVERING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780103 ↗
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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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