BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    Recall: Z-1240-2009 · Initiated February 9, 2009

    Recall

    Recall Number
    Z-1240-2009
    Event Number
    51492
    Firm
    Edwards Lifesciences, Llc
    FEI Number
    2015691
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 9, 2009
    Posted
    April 17, 2009
    Terminated
    April 11, 2011
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    Reason

    Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".

    Action

    Edwards initiated the worldwide recall via Urgent Customer Notification letters dated February 9, 2009 and are being sent by Federal Express starting on February 10, 2009. These letters are requesting that customers cease using Swan-Ganz" Continuous Cardiac Output (CCO) Thermodilution Catheter products from the indicated lots and that they return all unused product. Edwards Lifesciences requested that the customer provide written verification of stock and identify any unused product to be returned. Questions should be directed to Technical Service at 800-822-9837.

    Distribution

    Worldwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia, Australia, and Singapore.

    Quantity

    2,728 units