Events

Retiro De Equipo (Recall) de AGA AMPLATZER Vascular Plug

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 AGA Medical Corporation.

¿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
    33323
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0127-06
  • Fecha de inicio del evento
    2005-09-01
  • Fecha de publicación del evento
    2005-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-11-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41698
  • 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
    Device, Vascular, For Promoting Embolization - Product Code KRD
  • Causa
    Five lots of amplatzer vascular plugs were sterilized in a load that was not validated for the amplatzer vascular plug. however, only three of those five lots were distributed.
  • Acción
    Urgent Recall letters, dated 09/01/05, were sent to affected customers via email, facsimile and with follow-up delivery via USPS. OUS customers were notified via Federal Express. The letter described the situation, the lots being recalled and included a response form that was to be faxed back to AGA Medical.

Device

AGA AMPLATZER Vascular Plug
  • Modelo / Serial
    The three lots that were distributed are identified as Lot no. M05F10-11, M05F15-12 and M05F02-47.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom
  • Descripción del producto
    AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • Dirección del fabricante
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA