Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A Recalled by Edward Lifesciences, Llc Due to Flow restriction issues in a trifurcated IV set...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edward Lifesciences, Llc directly.
Affected Products
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.
Quantity: 13,077 (U.S.) and 12,306 (International)
Why Was This Recalled?
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edward Lifesciences, Llc
Edward Lifesciences, Llc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report