Edwards Lifesciences, LLC recalls ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninva…

Recall date

May 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1732-2015

FDA classification

Class II

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia, Estonia, Italy, Romania, Sweden, Austria, Finland, Kuwait, Saudi Arabia, Switzerland, Bahrain, France, Netherlands, Slovenia, Turkey, Belgium, Great Britain, Oman, Slovakia, South Africa, Bulgaria, Greece, Poland, South Afri…

Why it was recalled

Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.