Edwards Lifesciences, LLC recalls Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monit

Recalled December 6, 2023 · FDA recall Z-0410-2024 · Edwards Lifesciences

Hazard

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. · FDA Class II

Units

6,714 units

Sold at

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Description

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Product

Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Manufacturer(s)

Edwards Lifesciences, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →