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.
규제 업데이트2026년 9월 4일•1분 읽기
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 팀이 정리했습니다 · 출처: Health Canada
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