Events

Retiro De Equipo (Recall) de Myopore sutureless Myocardial Pacing Lead

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 Greatbatch Medical.

¿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
    53777
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0581-2010
  • Fecha de inicio del evento
    2009-09-01
  • Fecha de publicación del evento
    2009-12-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86499
  • 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
    Bipolar pacing lead, permanent pacemaker electrode - Product Code DTB
  • Causa
    The silicone tubing of affected leads was processed outside of validated parameters. although the material remains biocompatible, test data regarding the performance characteristics are not available.
  • Acción
    Customers were contacted by phone beginning 09/01/09. They were asked to hold product and determine if they had distributed any product. A written notification followed which identified the product, described the issue and asked for product to be returned. Product was distributed to two consignees and contained the following day. Questions are directed to the company at 612-559-2613.

Device

Myopore sutureless Myocardial Pacing Lead
  • Modelo / Serial
    Serial Numbers: 148399, 148400, 148401, 148402, 148403, 148404, 148405, 148406, 148407, 148408, 148409, 148410, 148411, 148412, 148413, 148414, 148415, 148416, 148417, 148418, 148419, 148420, 148421, 148422, 148423,  148424, 148427, 148430, 148431, 148433, 148434, 148435, 148436, 148437, 148438.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    CA and MN
  • Descripción del producto
    Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been sterilized by ethylene-oxide gas. Manufactured by: Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Dirección del fabricante
    Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
  • Empresa matriz del fabricante (2017)
    Integer Holdings Corporation
  • Source
    USFDA