BEUDAMED
    FDA Enforcement Class II Terminated

    Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.

    Recall: Z-0217-2015 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0217-2015
    Event ID
    69565
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2014
    Initiation Date
    October 8, 2014
    Classification Date
    November 14, 2014
    Termination Date
    December 15, 2016
    Address
    12050 Lone Peak Pkwy, N/A, Draper, UT, 84020-9414, United States

    Description

    Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.

    Reason

    Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.

    Code Info

    Lots: 59134589;59346136;59499481;59609044;59717943;59138591;59192007;59149674;59350916;59514123;59620244;59723313;59138592;59199148;59202405;59370449;59528372;59625386;59723318;59148881;59207364;59222648;59409903;59528392;59634884;59735991;59149673;59211452;59245610;59414824;59541717;59651860;59747795;59149675;59211456;59245648;59453572;59555076;59662625;59758989;59151406;59216325;59266772;59456447;59563964;59680248;59769429;59161706;59218844;59283731;59458072;59568501;59691477;59774986;59163769;59229509;59309184;59463365;59577224;59695811;59791798;59179981;59229512;59319451;59490087;59604744;59706987;59813426;59182987;59232182;59342295;59491855;59604746;59717942;59839270;59192002;59235535;59245625;59328438;59409901;59509316;59615872;59680180;59758991;59245650;59328440;59413359;59518784;59615876;59680270;59759002;59245652;59329235;59414819;59523751;59620242;59684868;59763554;59258285;59346138;59431972;59531242;59620243;59702379;59774995;59271794;59346146;59453598;59536690;59620327;59706982;59780342;59271795;59350911;59456450;59541842;59630423;59706985;59786179;59283729;59350921;59458056;59555081;59634892;59712080;59796688;59287254;59354987;59458061;59563850;59634893;59712081;59796692;59290438;59354988;59463367;59568469;59640081;59723317;59801791;59295439;59365157;59473421;59572996;59640085;59723320;59813418;59295506;59365159;59473422;59577180;59640108;59729757;59824882;59299876;59378069;59484139;59581494;59651780;59729759;59824891;59304307;59383861;59490088;59581564;59651850;59729761;59836965;59304308;59390115;59490089;59583327;59662626;59735981;59839272;59304310;59390121;59491856;59589933;59662638;59735983;59844549;59312984;59391051;59491858;59589951;59675187;59735987;59319447;59404539;59499480;59604747;59680142;59747805;59321329;59409878;59504238;59609041;59680148;59751061;

    Distribution

    Worldwide Distribution - USA including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia. US Territory: Puerto Rico and Internationally to Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Singapore, South Korea, Sri Lanka, Taiwan, and Venezuela.

    Quantity

    157,305