Events

Retiro De Equipo (Recall) de Device Recall HEARTSTRING Aortic Cutter 4.3 mm

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 Maquet Cardiovascular.

¿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
    56860
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1222-2011
  • Fecha de inicio del evento
    2010-06-04
  • Fecha de publicación del evento
    2011-02-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94678
  • 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
    Surgical Cutter - Product Code FZT
  • Causa
    Pouch integrity may be compromised, resulting in loss of sterility.
  • Acción
    Urgent Device Removal letters were sent out on June 10, 2020 by Federal Express. The letter identified the affected product, described the reason for the recall, and asked for all affected product to be returned. The firm asked customers to examine their inventory and to discontinue distributing the affected lots. In addition, customers are to complete and return the Field Action Response form. If the affected product was further distributed, those customers also need to be notified of the recall and return their affected product to their distributor. All affected returned products may be exchanged with other unaffected HEARTSTRING Aortic Cutter 4.3 MM devices. Customers are to contact their local MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874 to arrange for an exchange and if they have any questions.

Device

Device Recall HEARTSTRING Aortic Cutter 4.3 mm
  • Modelo / Serial
    Lot numbers 9081071 and 9082071.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of IA, KY, IL, WI, TX and NC and countries of Japan, Germany and Hong Kong.
  • Descripción del producto
    Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey. || Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.
  • Manufacturer
    Maquet Cardiovascular

Manufacturer

Maquet Cardiovascular
  • Dirección del fabricante
    Maquet Cardiovascular, 170 Baytech Dr, San Jose CA 95134-2302
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA