Edwards Pressure Monitoring Kit Recalled for Flow Restriction Issues
Edwards Lifesciences is recalling pressure monitoring kits due to flow restriction in the IV set, which may prevent system priming or line flushing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard involves a functional defect (flow restriction) that impedes device operation but does not explicitly report injuries, deaths, or high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Edwards Lifesciences, LLC is recalling the Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. The recall is due to flow restriction issues in the trifurcated IV set included in the kits.
The restriction of IV fluid flow may result in an inability to prime the system before use or difficulty in flushing the line after a blood draw. The affected products are sterile, single-use kits used for intravascular, intracranial, or intrauterine pressure monitoring.
The recall covers 13,077 units in the United States and 12,306 units internationally. Distribution was worldwide, including the US, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia. Healthcare facilities should stop using the affected lots and contact Edwards Lifesciences for instructions.
The recalled product
- Product
- Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
- Manufacturer
- Edward Lifesciences, Llc
Distribution
Distributed nationwide across the United States.
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