Retiro De Equipo (Recall) de Device Recall QuickDraw Venous Cannula

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 DWS
  • Causa
    Edwards is recalling the quickdraw venous cannula due to complaints of cannula separation during withdrawal of the device when the percutaneous insertion method is used.
  • Acción
    The firm, Edwards Lifesciences, sent an "URGENT FIELD SAFETY NOTICE PRODUCT RECALL - ACTION REQUIRED" notice dated May 14, 2013 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to review our entire inventory for any QuickDraw Venus Cannula that has not expired; quarantine affected product from your inventory; discontinue use and return unused devices; complete and return the acknowledgment form via fax to Edwards Customer Service on 800-422-9329 within three days of receipt of this Field Safey Notice; contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number and replacement product; return product to Edwards Lifesciences, Attn: Santosh Bhagat, 12050 Lone Peak Drive, Draper, UT 84020 Attention: RECALL, RGA#xxxxxx. If you have any questions that have not been answered by this notice, please call Edwards Customer Service at 800-424-3278 from the hours of 6:00AM - 4:30PM PST.


  • Modelo / Serial
    Model QD22: Lot No. 59049758, 59054488, 59067502, 59074170, 59081626, 59083736, 59091652, 59094887, 59114755, 59117451, 59134508, 59149651, 59154310, 59178579, 59201243, 59212118, 59222657, 59233636, 59233637, 59246684, 59246701, 59255899, 59255900, 59269439, 59284780, 59287725, 59296462, 59299605, 59315339, 59320575, 59334652, 59356129, 59360072, 59365198, 59365199, 59374009, 59384309, 59390552, 59394166, 59394167, 59421250, 59448841  Model QD25: Lot No. 59046082,59046847,59052393,59052395,59056270,59059029,59060798,59062681,59069772,59073141,59077234,59079573,59085168,59085169,59097289,59101637,59106005,59110720,59122491,59126281,59131923,59140133,59142266,59143453,59145027,59158524,59158579,59163164,59184252,59191107,59201246,59207044,59209886,59214360,59214361,59216991,59222658,59222659,59233651,59246685,59246703,59255901,59268625,59284781,59287728,59296463,59299610,59313057,59320582,59320583,59334656,59344191,59346468,59352608,59356135,59360084,59374014,59374015,59414791,59425355,59437699,59437700,59448853
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: US Nationwide and country of Canada.
  • Descripción del producto
    QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. || Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona¿ pyrogenic in a sealed, peel-type pouch.
  • Manufacturer


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