Recall of Edwards Lifesciences Swan-Ganz Catheters

Source: Health Canada · Canada

Health Canada has issued a recall for certain Edwards Lifesciences Swan-Ganz catheters due to complaints of leaks and breakage that may cause infection, medication loss, or blood loss.

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

This notice was issued by Health Canada on May 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, medical devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Health Canada has announced a recall for Edwards Lifesciences Swan-Ganz catheters due to complaints of leaks and breakage in the proximal injectate lumen hub, linked to manufacturing process and material changes. This issue occurs with frequent manipulation or flexing and may lead to infection, medication loss, and/or blood loss.

Which Products Are Affected

The affected products include:

  • Swan-Ganz CCO Catheters with lot numbers 66646367, 66646363, 66600646, 66704726, 66600645, 66660615, 66764454, and 66590392, all with model number 777F8.
  • Swan-Ganz IQ Pulmonary Artery Catheter with serial numbers 66417073 and 66417072, both with model number AIQSGF8.
  • Swan-Ganz Thermodilution Catheters with more than 20 serial numbers (contact manufacturer for details) and model number 131F7P. These products are manufactured by Edwards Lifesciences LLC, located at 1 Edwards Way, Irvine, California, United States, 92614.

What You Should Do

Consumers should contact the manufacturer, Edwards Lifesciences LLC, for information on affected serial numbers and further instructions, as specified for certain products in the recall notice.

Why This Matters

This recall highlights potential risks associated with medical devices that could lead to serious health issues, emphasizing the importance of addressing manufacturing defects to ensure patient safety.

Source

This recall information is from Health Canada, available at: https://recalls-rappels.canada.ca/en/alert-recall/edwards-lifesciences-swan-ganz-catheters

Original source: Health Canada Official Notice ↗

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Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Health Canada has issued a recall for certain Edwards Lifesciences Swan-Ganz catheters due to complaints of leaks and breakage that may cause infection, medication loss, or blood loss.
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.