AneurysmFlow Recall: Health Canada Issues Alert on Software Issue

Source: Health Canada · Canada

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 has announced a recall for AneurysmFlow due to unreliable prognostic information in the mafa ratio, which could influence clinical decisions despite warnings not to use it for such purposes.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on April 2, 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.

AneurysmFlow Recall

What Happened

Philips has determined that the mafa ratio in AneurysmFlow does not provide reliable prognostic information regarding aneurysm occlusion following flow diverter stent treatment. Although the instructions for use state that the mafa ratio should not be used for clinical decisions, it may still be considered during procedures, potentially leading to incorrect clinical judgments.

Which Products Are Affected

The affected product is AneurysmFlow with model or catalogue number 1.4. Lot or serial number is not applicable. No specific quantities, UPCs, or date ranges were provided in the recall notice.

What You Should Do

As per the instructions for use, do not use the mafa ratio for making clinical decisions. For further information, refer to the recall notice from Health Canada.

Why This Matters

This issue could result in incorrect clinical decisions during aneurysm treatments, potentially affecting patient safety and outcomes.

Source

This recall information is from Health Canada. For more details, visit https://recalls-rappels.canada.ca/en/alert-recall/aneurysmflow.

Original source: Health Canada Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Health Canada has announced a recall for AneurysmFlow due to unreliable prognostic information in the mafa ratio, which could influence clinical decisions despite warnings not to use it for such purposes.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.