Official recall record
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-09-04
- Last updated (per notice)
- 2026-10-07
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Gore has identified through quality control testing that some VIABAHN® devices were processed using equipment that was functioning outside of the validated range. This could potentially result in an incorrect bonding location of the distal tip onto the delivery catheter.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-10-16.
Record last checked against the registry on 2026-10-16.
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