Events

Retiro De Equipo (Recall) de Device Recall Medtronic Intrathecal Catheter Distal Revision Kit

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 Medtronic Neurological.

¿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
    35931
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1415-06
  • Fecha de inicio del evento
    2006-07-21
  • Fecha de publicación del evento
    2006-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47188
  • 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
    Intrathecal Catheter Distal Revision Kit - Product Code LKK
  • Causa
    Tip dislodgement during implantation-medtronic is recalling model 8731 intrathecal catheter and model 8598 intrathecal catheter distal revision kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.
  • Acción
    An Urgent Worldwide Medical Device Recall letter was sent to affected customers 07/20/06 for delivery on 07/21/06. The letter describes the issue, identifies the affected product and list action required by the customer. Affected devices are to be removed from active inventory, quarantined and returned to Medtronic for a warranty credit. A Reply card is asked to be returned. Medtronic Representatives will follow-up by July 28, 2006.

Device

Device Recall Medtronic Intrathecal Catheter Distal Revision Kit
  • Modelo / Serial
    Model 8598 Base Lot Numbers: B011468N, B011893N, B011894N, N0012129, N0012612, N0012969, N0012970, N0012971, N0014057, N0014058, N0014179, N0014180, N0016472.   *Model 8731 Catheters and model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom
  • Descripción del producto
    Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter) . Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
  • Manufacturer
    Medtronic Neurological

Manufacturer

Medtronic Neurological
  • Dirección del fabricante
    Medtronic Neurological, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA