Retiro De Equipo (Recall) de Edwards Lifesciences Vent Catheters

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Edwards Lifesciences, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    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.
  • Acción
    Edward Lifesciences sent an Urgent Medical Device Safety Notice date October 8, 2014, via Fed-Ex to all affected customers. On 3/4/15, letters were sent to surgeons. As part of the customer instructions in the safely notice, customers were requested to forward copies of the safely alert to any organization where the potentially affected devices have been transferred. No product is being returned. The distribution of the device has not been stopped as a result of this field correction. No additional production lots will be released for distribution until the IFU has been revised. Customers with questions were instructed to call (800) 424-3278. For questions regarding this recall call 801-553-7531.


  • Modelo / Serial
    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;
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer


  • Dirección del fabricante
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
  • Source