Official recall record

Edwards Lifesciences Swan-Ganz Catheters

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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