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.
Health Canada has issued an alert regarding this issue.
規制動向2026年9月4日•1分で読めます
Gore Reports Quality Issue with VIABAHN® Devices Potentially Affecting Tip Bonding
Gore discovered some VIABAHN® devices were processed on equipment outside the validated range, potentially causing incorrect distal tip bonding.
PharmaCountryチームがまとめました · 出典： Health Canada
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