GORE VIABAHN Endoprosthesis with Heparin VBH130202ARecalls & reported problems
W. L. Gore & Associates, Inc. · Class 3 · Implant
All models of GORE VIABAHN Endoprosthesis with Heparin (62)
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 00733132623273), received between Jan 15, 2019 and Jan 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2019Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure
THE FOLLOWING WAS REPORTED TO GORE: AN OPEN ELEPHANT TRUNK THORACIC ENDO GRAFT PROCEDURE WAS PERFORMED ON (B)(6) 2018. IT WAS REPORTED THAT A SHEATH AND GUIDEWIRE WERE NOT USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS. THE VIABAHN DEVICE WAS INSERTED INTO THE SUBCLAVIAN ARTERY FOR PERFUSION. THE DEPLOYMENT LINE SNAPPED DURING DEPLOYMENT, RESULTING IN A PARTIALLY CONSTRAINED VIABAHN DEVICE. THE VIABAHN DEVICE WAS REMOVED FROM PATIENT WITH NO ISSUES, AND A NEW VIABAHN DEVICE WAS INSERTED AND DEPLOYED IN THE SUBCLAVIAN ARTERY. IT WAS REPORTED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8250909 ↗
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- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
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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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