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Edwards lifesciences swan-ganz catheters
Official notice
29 Apr 2026
Last checked
29 Apr 2026
An official Health Canada notice concerns Edwards lifesciences swan-ganz catheters. There have been a growing number of complaints (outside of Canada) of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on Swan-Ganz catheters. The issue is linked to manufacturing process and material changes and is associated with situations where the (blue) proximal injectate hub and lumen experience frequent manipulation or flexing. Most complaints are associated with performance of bolus thermodilution cardiac output procedures. This has led to instances of leakage, lumen damage and breakage and may lead to infection, medication loss, and/or blood loss. Published 2026-04-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
81991
Official notice
2026-04-29
The hazard
The hazard
There have been a growing number of complaints (outside of Canada) of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on Swan-Ganz catheters. The issue is linked to manufacturing process and material changes and is associated with situations where the (blue) proximal injectate hub and lumen experience frequent manipulation or flexing. Most complaints are associated with performance of bolus thermodilution cardiac output procedures. This has led to instances of leakage, lumen damage and breakage and may lead to infection, medication loss, and/or blood loss.
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Brand: Edwards Lifesciences.
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Documents, notices & source
See the official notice and source documents for full details.
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