GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Health Canada recalls certain GORE VIABAHN Endoprosthesis with PROPATEN Bioactive devices due to potential incorrect distal tip bonding from manufacturing equipment issues.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on September 4, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.
What Happened
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.
Which Products Are Affected
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive
- Model PAJR081002B (more than 10 lot or serial numbers, contact manufacturer)
- Model PAHR131002B (more than 10 lot or serial numbers, contact manufacturer)
- Model PAJR071002B (more than 10 lot or serial numbers, contact manufacturer)
Additional affected units with more than 10 lot or serial numbers total; contact manufacturer for full list.
What You Should Do
Contact the manufacturer for information on affected lots.
Why This Matters
The recall involves a vascular medical device where manufacturing deviation could affect device integrity.
Source
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,057 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to September 4, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.