Recall Monitor
Health Products

GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
GORE® VIABAHN® Endoprosthesis with PROPATEN BioactiveMore than 10 numbers, contact manufacturer.PAJR081002B
GORE® VIABAHN® Endoprosthesis with PROPATEN BioactiveMore than 10 numbers, contact manufacturer.PAHR131002B
GORE® VIABAHN® Endoprosthesis with PROPATEN BioactiveMore 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.

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