Retiro De Equipo (Recall) de Transseptal Needle

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia Pty Ltd.

¿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 I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Cook medical has become aware that certain transseptal needles may be the incorrect length, and is initiating a recall of lot 8181945. potential adverse events may occur by using the nonconforming products, including being unable to perform the transseptal puncture. this could necessitate replacing the device or rescheduling the procedure. in addition, use of the nonconforming products could make the puncture less controlled, which could potentially lead to injury of the heart.
  • Acción
    Cook Medical is advising customers to quarantine affected stock from their inventory for return to the sponsor for a product credit as per the instructions given in the customer letter.


  • Modelo / Serial
    Transseptal NeedleLot Number: 8181945Reference Part Number: TSNC-18-71.0Global Part Number: G02364ARTG 155227
  • Manufacturer