Retiro De Equipo (Recall) de St. Jude Medical FASTCATH Hemostasis Introducer

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 St. Jude Medical.

¿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
    Wire, guide, catheter - Product Code DQX
  • Causa
    St. jude medical has initiated a voluntary recall of two lots of fast-cath hemostasis introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. they discovered that the product lots could contain some items which have been mis-labeled with the incorrect french size. in one case, the pouch label does not correctly identify the content of the pouch. in another.
  • Acción
    Field Representatives were sent a "St Jude Medical Urgent Product Information" letter to be hand delivered to their customers. The letter listed the products and problem and advised consignees to discontinue use of the product. A form was attached for the return of products to the firm. Contact your local St Jude Medical representative for further information.


  • Modelo / Serial
    Lot Number: 4219
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.
  • Descripción del producto
    St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. || Used for the introduction of catheters into a vessel.
  • Manufacturer


  • Dirección del fabricante
    St. Jude Medical, 14901 DeVeau Place, Minnetonka MN 55345
  • 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