Retiro De Equipo (Recall) de Protg "GPS" SelfExpanding Biliary Stent 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 Ev3, 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 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, biliary, diagnostic - Product Code FGE
  • Causa
    Mislabeled size: specific prot¿g¿ gps lots have product labeling that does not match the actual stent sizes contained in the packages. the affected product outer packaging is labeled as a 12 mm x 60 mm prot¿g¿ gps stent but contains a 14 mm x 60 mm stent. this situation can potentially result in vessel damage. conversely, a lot was labeled as a 14 mm x 60 mm prot¿g¿ gps stent but actually contai.
  • Acción
    ev3 issued a "Medical Device Recall" letter dated September 29, 2010 to consignees. The letter described the product, Issue Summary, & Required Action. Consignees are to review inventory and remove all affected devices. ev3 representatives will contact customers to arrange for the return and credit of unused product. ev3 can be reached at 800 716-6700 concerning this recall.


  • Modelo / Serial
    Lot 9199844 (REF SERB65-12-60-80) & 9199842 (REF SERB65-14-60-80).
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, VA, and WA.
  • Descripción del producto
    ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. || ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.
  • Manufacturer


  • Dirección del fabricante
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source