Health Canada29 Apr 2026
Edwards Lifesciences Swan-Ganz Catheters
Health Canada published a recall notice for Edwards Lifesciences Swan-Ganz Catheters on 29 Apr 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 29 Apr 2026
- Recall type
- Health product recall
- Companies
- Edwards Lifesciences LLC · 1 Edwards Way, Irvine, California, United States, 92614
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. Additional information Details Original published date: 2026-04-29 Affected products: Affected products Lot or serial number Model or catalogue number Swan-Ganz CCO Catheters 66646367 777F8 Swan-Ganz CCO Catheters 66646363 777F8 Swan-Ganz CCO Catheters 66600646 777F8 Swan-Ganz CCO Catheters 66704726 777F8 Swan-Ganz CCO Catheters 66600645 777F8 Swan-Ganz CCO Catheters 66660615 777F8 Swan-Ganz CCO Catheters 66764454 777F8 Swan-Ganz CCO Catheters 66590392 777F8 Swan-Ganz IQ Pulmonary Artery Catheter 66417073 AIQSGF8 Swan-Ganz IQ Pulmonary Artery Catheter 66417072 AIQSGF8 Swan-Ganz Thermodilution Catheters More than 20 serial numbers, contact manufacturer. 131F7P Swan-Ganz Thermodilution Catheters More than 20 serial numbers, contact manufacturer.
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.