GORE VIABAHN Endoprosthesis with Heparin VBJR072502ARecalls & reported problems
W. L. Gore & Associates, Inc. · VIABAHN SX ENDO HEPARIN 18 RO 7mmX25cm 7Fr120cm 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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132623792), received between Aug 5, 2016 and Nov 9, 2022 — classified as 1 injury, 4 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.
Most reported problems
Device problems
- Activation Failure2
- Positioning Failure2
- Difficult or Delayed Activation1
- Patient-Device Incompatibility1
Patient problems
- No Information2
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
- Occlusion1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2022Activation Failure; Activation Failure
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED FOR TREATMENT OF A STENOTIC SUPERFICIAL FEMORAL ARTERY UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE PHYSICIAN WAS ABLE TO ADVANCE AND PLACE THE VIABAHN DEVICE AT THE INTENDED LOCATION. WHEN THE PHYSICIAN PULLED THE DEPLOYMENT LINE, THE LINE BROKE AFTER THE VIABAHN HAD EXPANDED DISTALLY BY APPROXIMATELY 0.5 CM. THE PHYSICIAN CUT THE HUB OF THE DEPLOYMENT SYSTEM AND ATTEMPTED TO PULL THE REMAINING FRAGMENT OF THE LINE TO COMPLETE EXPANSION. HE WAS UNABLE TO COMPLETE DEPLOYMENT AND DECIDED TO REMOVE THE VIABAHN BY RE-SHEATHING THE MOSTLY CONSTRAINED DEVICE. HE WAS ABLE TO REMOVE THE VIABAHN BY RE-SHEATHING IT USING A 7 FR SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE VIABAHN DEVICE. NO IMPACTS TO THE PATIENT WERE REPORTED. THE PHYSICIAN BELIEVES HE MAY HAVE PULLED THE DEPLOYMENT LINE TOO FORCEFULLY ON THE INITIAL VIABAHN, CAUSING THE LINE TO BREAK. TWO OTHER VIABAHNS WERE IMPLANTED WITHOUT ISSUE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15764169 ↗MalfunctionOct 21, 2022Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED FOR TREATMENT OF PERIPHERAL ARTERIAL DISEASE IN THE RIGHT LOWER SUPERFICIAL FEMORAL ARTERY UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE CALCIFIED LESION WAS PRE-BALLOONED PRIOR TO TREATMENT. THE PHYSICIAN LOADED THE VIABAHN DEVICE OVER AN 0.014" GUIDEWIRE AND ADVANCED TO THE AREA OF TREATMENT THROUGH A 7 FR SHEATH. WHEN THE PHYSICIAN PULLED THE DEPLOYMENT LINE THE VIABAHN DIDN'T DEPLOY AND THERE WAS NO REPORTED EXPANSION. THE PHYSICIAN THEN ATTEMPTED TO RE-SHEATH THE VIABAHN DEVICE FOR REMOVAL, BUT WAS UNSUCCESSFUL. DURING ATTEMPTS TO REMOVE THE VIABAHN, THE DEVICE EXPANDED DISTALLY BY APPROXIMATELY 4 CM WITHIN THE PATIENT. THE PARTIALLY DEPLOYED VIABAHN WAS REMOVED FROM THE PATIENT ALONG WITH THE SHEATH. AN ALTERNATE 6 X 25 VIABAHN DEVICE WAS USED TO COMPLETE THE PROCEDURE UTILIZING A 0.035" GUIDEWIRE WITHOUT A SHEATH. REPORTEDLY THE PATIENT EXPERIENCED HEMATOMA DUE TO THE EVENT.
Patient problems: Hematoma
MAUDE report 15651009 ↗InjuryDec 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WAS TREATED FOR STENOTIC OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY USING TWO GORE® VIABAHN® ENDOPROSTHESES. IT WAS REPORTED BOTH DEVICES WERE DELIVERED IN THEIR INTENDED LOCATION WITHOUT ISSUE. ON THE SAME DATE, POST OPERATION, OCCLUSION OF THE DEVICES WAS IDENTIFIED. THE PHYSICIAN STATED THE SUSPECTED CAUSE OF THE OCCLUSIONS IS UNKNOWN. A REINTERVENTION WAS PERFORMED TO TREAT THE STENOSIS. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: Occlusion
MAUDE report 10950639 ↗MalfunctionAug 5, 2016Positioning Failure
MalfunctionAug 5, 2016Positioning Failure
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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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