Public recall detail

GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive

2026-09-04

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Health products Health product recall
Quick summary

Quick summary: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive. Reason: Health product recall. Category: Health products. Date: 2026-09-04.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive. Reason: Health product recall. Category: Health products. Date: 2026-09-04.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandW.L. Gore & Associates Inc
ProductGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82600

Affected products

ProductGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
LotMore than 10 numbers, contact manufacturer.
ModelPAJR081002B
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
ProductGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
LotMore than 10 numbers, contact manufacturer.
ModelPAHR131002B
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
ProductGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
LotMore than 10 numbers, contact manufacturer.
ModelPAJR071002B
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesW. L. Gore & Associates, Inc. 1505 North 4th Street, Flagstaff, Arizona, United States, 86004
Recall date2026-09-03
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82600
Background{}
CompaniesW. L. Gore & Associates, Inc. 1505 North 4th Street, Flagstaff, Arizona, United States, 86004
AudiencesHealthcare
Source updated2026-09-04

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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