GORE VIABAHN Endoprosthesis Recalled Over Tip Bonding Flaw: Health Canada

Health Canada has classified a recall of the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive surface as a Type II health product recall, a designation reserved for issues that could cause temporary or reversible health consequences. The recall, dated 2026-09-03 and published on 2026-09-04, was issued after manufacturer W. L. Gore & Associates, Inc. flagged a manufacturing defect tied to specific production equipment.

The affected item is a cardiovascular implant used in vascular procedures, marketed under the Gore brand and distributed for use by healthcare providers rather than sold directly to consumers. Health Canada’s notice lists the recall under the identification number RA-82600, and the action falls within the agency’s medical devices and cardiovascular product category.

What Went Wrong?

According to Health Canada, Gore identified the problem through its own internal quality control testing. The company found that some VIABAHN® devices were processed using equipment operating outside of its validated performance range. That deviation, the notice explains, could potentially result in an incorrect bonding location of the distal tip onto the delivery catheter.

In practical terms, this means the connection between the device’s tip and the catheter used to deliver and position it inside a patient’s blood vessel may not be secured exactly where it should be. For an implant designed to reinforce or open narrowed or blocked arteries, a bonding irregularity at the delivery stage raises the possibility of complications during placement, since the distal tip’s positioning is critical to how the device deploys and seats correctly.

Recalled Products at a Glance

Health Canada’s affected products table lists the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive under three separate model or catalogue numbers:

• Model/catalogue number PAJR081002B
• Model/catalogue number PAHR131002B
• Model/catalogue number PAJR071002B

For each of these, Health Canada notes that the affected lot or serial numbers run to ‘more than 10 numbers’ and directs healthcare facilities and clinicians to contact the manufacturer directly for the complete list of impacted units rather than publishing every number in the public notice.

Who Should Be Concerned

This recall is directed at a healthcare audience rather than the general public. Hospitals, vascular surgeons, interventional radiologists, and other clinical staff who may have GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive devices in stock — particularly under the three listed model numbers — are the primary parties affected. Patients who have already had one of these devices implanted are not asked to take independent action under this notice; any clinical follow-up would be determined by their treating physician in consultation with the manufacturer.

What Should You Do?

Health Canada’s guidance for this recall is direct: contact the manufacturer if additional information is required. For clinicians and facility staff managing inventory, that means reaching out to W. L. Gore & Associates, Inc. to confirm whether specific units on hand fall within the affected lot numbers under the listed model numbers, and to receive instructions on how to handle any implicated stock.

Health Canada also encourages anyone who becomes aware of a health or safety concern connected to a recalled product to report it through the department’s official reporting channel, and offers an email subscription service so the public and healthcare professionals can be notified automatically about new or updated recalls and safety alerts.

From the Agency

Per the notice published by Health Canada, the issue statement reads that Gore identified through quality control testing that some VIABAHN devices were processed using equipment functioning outside of the validated range, which could potentially result in an incorrect bonding location of the distal tip onto the delivery catheter. The recall is listed under company W. L. Gore & Associates, Inc., based in Flagstaff, Arizona, and remains classified as a Type II recall as of the most recent update on 2026-09-04.