Retiro De Equipo (Recall) de Device Recall CloverSnare 4Loop Vascular Retrieval Snare

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 Cook Inc..

¿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 1
  • 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
    Device, percutaneous retrieval - Product Code MMX
  • Causa
    This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
  • Acción
    Cook Medical sent an Urgent Medical Device Recall letter dated July 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the attached list of affected products and lot numbers shipped to their account, and quarantine any affected product that remains unused. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. Complete the attached Recalled Product Reply Form and return to Cook Medical either with the product or separately. Customers were asked to report any Adverse Event to Cook Medical Customer Relations at 800-457-4500 or 1-812-339-2235.


  • Modelo / Serial
    Model Number(s): VRS-6.0-9.0 Lot numbers: 3583416, 3583418, 3583422, 3583424, 3583426, 3583428, 3583430, 3583432, 3583434, 3583436, 3583440, 3583442, 3583452, 3583456, 3583458, 3583462, 3583464, 3583466, 3583468, 3583470, 3583472, 3583474, 3583476, 3583478, 3583480, 3583482, 3583484, 3583486, 3583488, 3583490, 3583492, 3583494, 3583496, 3583498, 3583500, 3583502, 3583504, 4293921, 4293923, 4293925, 4293927, 4319573, 4319575, 4319577, 4319579, 4319581, 4319583, 4319585, 4319587, 4319589, 4319591, 4572365, 3583418X, 3583430X, 3583442X, 3583442XX, 3583464XXX, 3583480XX, and 3583486X.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA including AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TX, UT, VA, WA, WI, WV and Internationally to: Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden, and Switzerland.
  • Descripción del producto
    CloverSnare 4-Loop Vascular Retrieval Snare. || Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. || The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.
  • Manufacturer


  • Dirección del fabricante
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Empresa matriz del fabricante (2017)
  • Source