Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Acumen IQ Sensor with VAMP System Recalled by Edwards Lifesciences, LLC Due to Their is the potential for flushing difficulties during...
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 Edwards Lifesciences, LLC directly.
Affected Products
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Quantity: 6,714 units
Why Was This Recalled?
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edwards Lifesciences, LLC
Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report