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Health Canada Medical devices

GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive

Issued September 3, 2026
Issue
Product GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
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.
Product
Product name
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
Reference
ID
RA-82600