Events

Retiro De Equipo (Recall) de Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories

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 Atricure Inc.

¿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
    64404
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0912-2013
  • Fecha de inicio del evento
    2013-01-14
  • Fecha de publicación del evento
    2013-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116050
  • 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 device, for ablation of cardiac tissue - Product Code OCL
  • Causa
    Products from lot no. 41865 may have been sent out with incorrect instructions for use (ifu) labeling.
  • Acción
    AtriCure sent a Urgent Medical Device Recall/Correction letter dated January 14, 2013, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. If the MAX1 is used as intended there is no risk to the patient as a result of this issue. The correct instructions for Use for the MAX1 Pen is included with this notification. AtriCure will replace any affected product if requested by the facility. Please review and fill out the attached " Acknowledgement Form" and either fax to AtriCure at (513) 644-4753. If you need to contact customer service, their number is 1-866-349-2342.

Device

Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories
  • Modelo / Serial
    Model Number(s): MAX1 A000163, Lot Number 41865
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of MD, PA and TX.
  • Descripción del producto
    Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
  • Manufacturer
    Atricure Inc

Manufacturer

Atricure Inc
  • Dirección del fabricante
    Atricure Inc, 6217 Centre Park Drive, West Chester OH 45069
  • Empresa matriz del fabricante (2017)
    Atricure Inc
  • Source
    USFDA