BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1732-2015 · Initiated May 18, 2015

    Recall

    Recall Number
    Z-1732-2015
    Event Number
    71246
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 18, 2015
    Posted
    June 9, 2015
    Terminated
    November 6, 2015
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

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

    Reason

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

    Action

    Edwards Lifesciences sent an URGENT Product Notification letter dated May 12, 2015, to all affected customers. The letter informed customers that Edwards Lifesciences has received reports that a component of the ClearSight System can be damaged if not handled properly. The letter informs customers of the problems identified and the actions to be taken. Customers with questions are instructed to call Edwards Technical Support. For questions regarding this recall call 949-250-2500.

    Distribution

    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 Africa, United Arab Emirates, Czech Republic, Hungary, Portugal, Spain, Denmark, Ireland, and Qatar.

    Quantity

    1,309 units total (696 units in US)