Notificaciones De Seguridad De Campo acerca de Imager ii angiographic catheter

Según Agency for Medical Products and Medical Devices of Croatia, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Croatia que fue producido por Boston Scientific Corporation, USA.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.
  • Notas adicionales en la data
    Medical Intertrade d.o.o., the registration holder of this medical device in Croatia, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the volontary withrawal of certain batches of medical devices IMAGER II angiographic catheter, manufactured by Boston Scientific Corporation, USA, due to a detected quality defects in certain product batches.
    Boston Scientific Corporation, USA, the manufacturer , has received reclamations about defective packagings, resulted from physical interactions between the carton on the pouch where the hub is located which may cause contamination of the product. Therefore, the manufacturer has taken precautions measures and decided to withraw all the affected batches.
    IMAGER II angiographic catheters are sterile, single-use diagnostic intravascular catheters used exclusively in Health Care Facilities, are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.).
    Medical Intertrade d.o.o., the registration holder of this medical device in Croatia, has recalled all nine batches found on the Croatian market affected by afore mentioned defect.
    None of the adverse events referred to the described packaging defect of IMAGER II angiographic catheter has been reported by now in the Republic of Croatia.
    The manufacturer has run an investigation and has found out the cause for packaging defects and has initiated corrective measures in order to prevent the reappearence of those defects.


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source