Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
EV1000 Clinical Platform Recalled by Edwards Lifesciences, LLC Due to Potential for an electrical short circuit leading to...
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
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).
Quantity: 22443
Why Was This Recalled?
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
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