Edwards Lifesciences Swan-Ganz Catheters
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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. | 834F75 |
| Swan-Ganz Thermodilution Catheters | More than 20 serial numbers, contact manufacturer. | 831F75P |
| Swan-Ganz Thermodilution Catheters | More than 20 serial numbers, contact manufacturer. | 141F7 |
| Swan-Ganz Thermodilution Catheters | More than 20 serial numbers, contact manufacturer. | 151F7 |
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
Edwards Lifesciences LLC
1 Edwards Way, Irvine, California, United States, 92614
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