Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Heparin Activity Failure
Edwards Lifesciences is recalling 978 Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters because they failed internal statistical tests for heparin activity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a failure to meet internal statistical requirements rather than a confirmed high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
Edwards Lifesciences, LLC is recalling 978 units of Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters, model number 744HF75. These flow-directed pulmonary artery catheters are used with the Vigilance Monitor to monitor cardiac output, mixed venous oxygen saturation, and end diastolic volume.
The recall was initiated because the product failed to meet the internal established statistical test requirement for heparin activity. The affected units are identified by lot number 59860969.
The products were distributed worldwide, including the United States, Canada, and several European countries. Healthcare facilities and distributors should stop using the affected catheters and contact Edwards Lifesciences for further instructions.
The recalled product
- Product
- Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 978
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot number 59860969.
Distribution
Distributed nationwide across the United States.
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