Events

Alerta De Seguridad para Innova™ Self-Expanding Stent System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Boston Scientific Corporation.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2011-09-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110902.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Fda class i recall: boston scientific innova™ self-expanding stent system fda has issued a class i recall on the boston scientific innova™ self-expanding stent system. a total of 72 products are affected and the manufacturer, boston scientific corporation, is conducting a recall of these products. the innova™ self-expanding stent system is indicated for the treatment of peripheral vascular lesions. the manufacturer has received 6 complaints involving no deployment or partial deployment of the innova stents. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and emergency surgery to remove the partially deployed stent. this recall does not affect stents that have already been implanted, as the issue occurs during delivery of the stent. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda link: http://www.Fda.Gov/safety/recalls/enforcementreports/ucm270461.Htm if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Innova™ Self-Expanding Stent System

Manufacturer

Boston Scientific Corporation
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • 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
    DH