🇨🇦 GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
Hazard/Reason: 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.
This page links to official sources. Verify model/lot/batch details in the official notice.