FDAMarch 21, 2019device
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).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
What to do
FDA enforcement status: Terminated
Brands named
edwards lifesciencesedwards
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO2026-03-27
- FDACytal Burn Matrix 10x15 cm. Product ID: BMM1015.2026-03-19
- FDACytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.2026-03-19
- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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