Reported May 29, 2019 · Terminated

EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid…

Edwards Lifesciences, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688

Is this the product you have?

  • EV1000 Clinical Platform
  • Models
    • EV1000A
    • EV1000NI
  • EV1000CS Product UsageEV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor)
Lot codes and dates
  • All lots
Amount recalled
22443

Where it was sold

Why it was recalled

Stop using this product now

Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 28, 2023 · Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.