CanadaEdwards Lifesciences Swan‑Ganz catheters — including Swan‑Ganz CCO, Swan‑Ganz IQ Pulmonary Artery and Swan‑Ganz Thermodilution catheter models (catalogue numbers such as 777F8, AIQSGF8, 131F7P, 834F75, 831F75P, 141F7 and 151F7 and specific lot/serial numbers listed by the manufacturer) — are affected and can be recognised by the (blue) proximal injectate lumen hub. The recall was issued because complaints of leaks, lumen damage and breakage of the blue proximal injectate hub linked to manufacturing and material changes may lead to leakage, infection, medication loss and/or blood loss, often during bolus thermodilution procedures. Contact the manufacturer for additional information.
What's being recalled
Companies: Edwards Lifesciences LLC, 1 Edwards Way, Irvine, California, United States, 92614.
How to identify it
Affected products: Swan-Ganz CCO Catheters; Lot or serial number: 66646367; Model or catalogue number: 777F8
Affected products: Swan-Ganz CCO Catheters; Lot or serial number: 66646363; Model or catalogue number: 777F8
Affected products: Swan-Ganz CCO Catheters; Lot or serial number: 66600646; Model or catalogue number: 777F8
Affected products: Swan-Ganz CCO Catheters; Lot or serial number: 66704726; Model or catalogue number: 777F8
Affected products: Swan-Ganz CCO Catheters; Lot or serial number: 66600645; Model or catalogue number: 777F8
Affected products: Swan-Ganz CCO Catheters; Lot or serial number: 66660615; Model or catalogue number: 777F8
Affected products: Swan-Ganz CCO Catheters; Lot or serial number: 66764454; Model or catalogue number: 777F8
Affected products: Swan-Ganz CCO Catheters; Lot or serial number: 66590392; Model or catalogue number: 777F8
Affected products: Swan-Ganz IQ Pulmonary Artery Catheter; Lot or serial number: 66417073; Model or catalogue number: AIQSGF8
Affected products: Swan-Ganz IQ Pulmonary Artery Catheter; Lot or serial number: 66417072; Model or catalogue number: AIQSGF8
Affected products: Swan-Ganz Thermodilution Catheters; Lot or serial number: More than 20 serial numbers, contact manufacturer.; Model or catalogue number: 131F7P
Affected products: Swan-Ganz Thermodilution Catheters; Lot or serial number: More than 20 serial numbers, contact manufacturer.; Model or catalogue number: 834F75
Affected products: Swan-Ganz Thermodilution Catheters; Lot or serial number: More than 20 serial numbers, contact manufacturer.; Model or catalogue number: 831F75P
Affected products: Swan-Ganz Thermodilution Catheters; Lot or serial number: More than 20 serial numbers, contact manufacturer.; Model or catalogue number: 141F7
Affected products: Swan-Ganz Thermodilution Catheters; Lot or serial number: More than 20 serial numbers, contact manufacturer.; Model or catalogue number: 151F7
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)