GORE VIABAHN Endoprosthesis VBCR060502ARecalls & reported problems

W. L. Gore & Associates, Inc. · VIABAHN SX ENDO 35 RO 6mmX5cm 7Fr 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 00733132623396), received between Mar 7, 2025 and Mar 7, 2025 — 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Activation Failure1

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.

MalfunctionMar 7, 2025Activation Failure; Activation Failure
THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, TREATMENT FOR A FISTULA WAS BEING PERFORMED IN THE PATIENT'S ARM. A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS TO BE IMPLANTED, BUT THE DEPLOYMENT LINE WAS STUCK. THERE WAS NO DEVICE EXPANSION. THE VIABAHN DEVICE WAS REMOVED WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES DUE TO THE NON-DEPLOYMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21549778 ↗

Device details

UDI-DI	`00733132623396`
Brand	GORE VIABAHN Endoprosthesis
Model	VBCR060502A
Company	W. L. Gore & Associates, Inc.
Product code	PFV · System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
Class	Class 3
FDA submission	P040037, P130006
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Dec 11, 2024

Device type (GMDN): Peripheral artery endovascular stent-graft, non-medicated

A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is a metallic mesh-like structure with a synthetic polymer tube (endovascular graft); it does not include pharmaceuticals.

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All System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment devices →

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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