Recall of Edwards Lifesciences Swan-Ganz Catheters
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 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 April 29, 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, cpsc, medical devices.
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 ↗
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 (1,545 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 29, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.