CanadaGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive (models PAJR081002B, PAHR131002B, PAJR071002B; affected lot/serial numbers: more than 10 numbers, contact the manufacturer) is affected. Testing found some devices were processed using equipment outside the validated range, which could result in an incorrect bonding location of the distal tip onto the delivery catheter. Contact the manufacturer if you require additional information.
What's being recalled
Companies: W. L. Gore & Associates, Inc., 1505 North 4th Street, Flagstaff, Arizona, United States, 86004.
How to identify it
Affected products: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: PAJR081002B
Affected products: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: PAHR131002B
Affected products: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: PAJR071002B
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)