Actualités réglementaires4 sept. 2026•1 min de lecture

Gore Reports Quality Issue with VIABAHN® Devices Potentially Affecting Tip Bonding

Par l'équipe PharmaCountry

Gore discovered some VIABAHN® devices were processed on equipment outside the validated range, potentially causing incorrect distal tip bonding.

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.

Compilé par l'équipe PharmaCountry · Source : Health Canada

Sujets :#device alert #quality control #VIABAHN #Gore #vascular devices