Retiro De Equipo (Recall) de Device Recall Covidien Endo GIA

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 Covidien LP.

¿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
    Endo GIA AutoSuture Universal Loading Unit - Product Code GDW
  • Causa
    Single use loading unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention.
  • Acción
    Covidien notified customers with an Urgent Medical Device Recall notification on February 11, 2013. The letter identified the affected product and the reason for the recall. Accounts were requested to quarantine and discontinue use of the affected devices, and notify Universal Loading Unit 30mm-2.0mm users of this recall. Customers should follow the instructions provided in order to return the affected product. Customers are to complete and return the Product Return Form regardless if they have any affected product or not. For questions regarding the RGA I return process, please contact Covidien Customer Service, M-F, 8 am - 6:30 pm ET at (800) 962-9888, option 1, and then option 2.


  • Modelo / Serial
    Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
  • Descripción del producto
    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm || Product Code: 030450 || Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
  • Manufacturer


  • Dirección del fabricante
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • 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