Retiro De Equipo (Recall) de Device Recall StarClose SE Vascular Closure System

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 Abbott Vascular.

¿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
  • 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, hemostasis, vascular - Product Code MGB
  • Causa
    Abbott vascular is recalling the starclose se vascular closure system because it may exhibit difficulty or failure to deploy the starclose se clip.
  • Acción
    An urgent field safety notice will be sent to customers on 2/10/17 to inform them that Abbott Vascular has initiated a recall regarding specific lots of the StarClose SE Vascular Closure System. Customers are informed that product from the identified lots may exhibit difficulty or failure to deploy the StarClose SE Clip. Potential risks associated with this event include prolonged procedure times, use of another device or manual compression to achieve hemostasis. Customers are instructed of the actions to be taken and what Abbott Vascular is doing about the recall. Customers with any questions are instructed to contact their local Abbott Vascular Representative or Customer Service Department at (800) 227-9902.


  • Modelo / Serial
    Part No. 14679-01 50908K1 50916K1 51013K1 51021K1 51106K1 5101241 5101441 5101941 5102141 5102741 5103141 5110541 5111041 5121041 5121541 5121741 5122341 6012641 6012941 6020341 6020841 6021141 6021641 6021841 6022541 6022941 6030341 6030841 6041241  Part No. 14679-02 50831K1 50903K1 50911K1 50921K1 50924K1 50929K1 51002K1 51008K1 51016K1 51026K1 51029K1 51103K1 5111741 5112041 5112441 5112741 5120141 5120441 6010641 6011141 6011441 6011941 6012241 6031041 6031541 6032241 6032941 6041941 6042141 6042641 6042941 6051141 6051341 6051941 6052441 6061541 6100341
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,
  • Descripción del producto
    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. || The UDI is 08717648079467. || The GMDN is 47411.
  • Manufacturer


  • Dirección del fabricante
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source