GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive |
More than 10 numbers, contact manufacturer. |
PAJR081002B |
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive |
More than 10 numbers, contact manufacturer. |
PAHR131002B |
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive |
More than 10 numbers, contact manufacturer. |
PAJR071002B |
Issue
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.
Additional information
Details
W. L. Gore & Associates, Inc.
1505 North 4th Street, Flagstaff, Arizona, United States, 86004
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