Health Canada has issued an alert after Gore identified, through quality‑control testing, that a subset of its VIABAHN® endoprosthesis devices were processed using equipment that was operating outside the validated range. This condition could potentially lead to an incorrect bonding location of the distal tip onto the delivery catheter.
Manufacturers and users are advised to review the affected product batches and follow any further guidance from Health Canada regarding corrective actions or product handling.
規制動向2026年9月4日•1分で読めます
Gore VIABAHN® Device Quality Issue Identified
Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.
PharmaCountryチームがまとめました · 出典： Health Canada
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