Events

Retiro De Equipo (Recall) de EverCross .035" OTW PTA Catheter (Balloon dilatation angioplasty catheter)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien 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
    Recall
  • ID del evento
    RC-2014-RN-00431-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00431-1
  • 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
    Covidien is conducting a recall of two production lots of the evercross 0.035 pta balloon catheter because of a product labelling error. based on customer reports and covidien's internal investigation, it has been identified that there is a discrepancy in the pta balloon length and the delivery catheter length printed on the product labelling.
  • Acción
    Customers are advised to immediately discontinue the use of the affected device and segregate this product from other inventory for returning to Covidien

Device

EverCross .035" OTW PTA Catheter (Balloon dilatation angioplasty catheter)
  • Modelo / Serial
    EverCross .035" OTW PTA Catheter (Balloon dilatation angioplasty catheter)Product code: AB35W06120135 and AB35W06040080Lot numbers: 9855406 and 9855291ARTG number: 172929
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    DHTGA