GORE VIABAHN Endoprosthesis with Heparin VBJR070702ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO HEPARIN 18 RO 7mmX7.5cm 7Fr 120cm Cath · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132624102), received between May 10, 2024 and Oct 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (2 reports).
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
- Activation Failure2
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2024Activation Failure; Activation Failure
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR AN UNKNOWN ANATOMICAL LOCATION DURING TREATMENT OF AN UNKNOWN ETIOLOGY. IT WAS REPORTED, DURING THE ATTEMPTED USE, THE VSX DEVICE WOULD NOT DEPLOY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20474664 ↗MalfunctionMay 10, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024 THE PATIENT UNDERWENT TREATMENT FOR STENOSIS IN THE LEFT ILIAC ARTERY USING GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS REPORTED THAT THE PHYSICIAN DID NOT PRE DILATE THE TARGET TREATMENT AREA. EVEN SO, THE PHYSICIAN WAS ABLE TO REACH THE LEFT ILIAC ARTERY GOING THROUGH A TERUMO 7FR SHEATH AND OVER A BOSTON SCIENTIFIC V-18¿ CONTROLWIRE¿ GUIDEWIRE WITH NO RESISTANCE. THE PHYSICIAN WENT TO INITIATE DEPLOYMENT BY PULLING THE DEPLOYMENT LINE WHERE THE DEPLOYMENT LINE BECAME STUCK AFTER PULLING 2-3INCHES. SOME FORCE WAS USED IN ATTEMPT TO PULL THE DEPLOYMENT LINE FURTHER, HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN REMOVED THE VIABAHN DEVICE IN TANDEM WITH THE SHEATH AND COMPLETED THE PROCEDURE BY USING TWO NEW VIABAHN DEVICES. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19293922 ↗
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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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