Quick summary
Quick summary: Edwards Lifesciences Swan-Ganz Catheters. Reason: Performance. Category: Cardiovascular. Date: 2026-04-29.
Public recall detail
Edwards Lifesciences Swan-Ganz Catheters
2026-04-29
Cardiovascular
Performance
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Edwards Lifesciences Swan-Ganz Catheters. Reason: Performance. Category: Cardiovascular. Date: 2026-04-29.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandEdwards Lifesciences LLC
ProductEdwards Lifesciences Swan-Ganz Catheters
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81991
Affected products
ProductSwan-Ganz CCO Catheters
Lot66646367
Model777F8
Serial number66646367
DescriptionSwan-Ganz CCO Catheters
ProductSwan-Ganz CCO Catheters
Lot66646363
Model777F8
Serial number66646363
DescriptionSwan-Ganz CCO Catheters
ProductSwan-Ganz CCO Catheters
Lot66600646
Model777F8
Serial number66600646
DescriptionSwan-Ganz CCO Catheters
ProductSwan-Ganz CCO Catheters
Lot66704726
Model777F8
Serial number66704726
DescriptionSwan-Ganz CCO Catheters
ProductSwan-Ganz CCO Catheters
Lot66600645
Model777F8
Serial number66600645
DescriptionSwan-Ganz CCO Catheters
ProductSwan-Ganz CCO Catheters
Lot66660615
Model777F8
Serial number66660615
DescriptionSwan-Ganz CCO Catheters
ProductSwan-Ganz CCO Catheters
Lot66764454
Model777F8
Serial number66764454
DescriptionSwan-Ganz CCO Catheters
ProductSwan-Ganz CCO Catheters
Lot66590392
Model777F8
Serial number66590392
DescriptionSwan-Ganz CCO Catheters
ProductSwan-Ganz IQ Pulmonary Artery Catheter
Lot66417073
ModelAIQSGF8
Serial number66417073
DescriptionSwan-Ganz IQ Pulmonary Artery Catheter
ProductSwan-Ganz IQ Pulmonary Artery Catheter
Lot66417072
ModelAIQSGF8
Serial number66417072
DescriptionSwan-Ganz IQ Pulmonary Artery Catheter
ProductSwan-Ganz Thermodilution Catheters
LotMore than 20 serial numbers, contact manufacturer.
Model131F7P
Serial numberMore than 20 serial numbers, contact manufacturer.
DescriptionSwan-Ganz Thermodilution Catheters
ProductSwan-Ganz Thermodilution Catheters
LotMore than 20 serial numbers, contact manufacturer.
Model834F75
Serial numberMore than 20 serial numbers, contact manufacturer.
DescriptionSwan-Ganz Thermodilution Catheters
ProductSwan-Ganz Thermodilution Catheters
LotMore than 20 serial numbers, contact manufacturer.
Model831F75P
Serial numberMore than 20 serial numbers, contact manufacturer.
DescriptionSwan-Ganz Thermodilution Catheters
ProductSwan-Ganz Thermodilution Catheters
LotMore than 20 serial numbers, contact manufacturer.
Model141F7
Serial numberMore than 20 serial numbers, contact manufacturer.
DescriptionSwan-Ganz Thermodilution Catheters
ProductSwan-Ganz Thermodilution Catheters
LotMore than 20 serial numbers, contact manufacturer.
Model151F7
Serial numberMore than 20 serial numbers, contact manufacturer.
DescriptionSwan-Ganz Thermodilution Catheters
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.
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesEdwards Lifesciences LLC 1 Edwards Way, Irvine, California, United States, 92614
Recall date2026-04-08
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81991
Background{}
CompaniesEdwards Lifesciences LLC 1 Edwards Way, Irvine, California, United States, 92614
AudiencesHealthcare
Source updated2026-04-29
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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