Events

Retiro De Equipo (Recall) de US Safire Duo Ablation Catheter MediGuide Enabledand Cool Path Duo Ablation Catheter, MediGuide Enab

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 St. Jude 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
    66597
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0174-2014
  • Fecha de inicio del evento
    2013-10-11
  • Fecha de publicación del evento
    2013-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122676
  • 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
    catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • Causa
    St. jude medical cardiovascular and ablation technologies division is performing a voluntary notification regarding selected batches of coolpath duo ablation catheter mediguide enabled products and safire duo ablation catheter mediguide enabled. these units were inadvertently shipped with the incorrect version of the instructions for use (ifu).
  • Acción
    The firm, St. Jude Medical (SJM), sent a "Urgent Medical Device Notice" dated 11 October 2013 to its consignees. The letter described the problem, the product involved in the recall and the actions to be taken. The consignees were instructed to discard the IFU received with the batches and replace it with the IFU received in conjunction with the notification letter. SJM has determined that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU. If you have any questions, contact Vice President, Quality, at 651-756-5402.

Device

US Safire Duo Ablation Catheter MediGuide Enabledand Cool Path Duo Ablation Catheter, MediGuide Enab
  • Modelo / Serial
    Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    US distribution: KS, MA, UT,TX, KY, OH.
  • Descripción del producto
    US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. || The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Dirección del fabricante
    St. Jude Medical, 5050 Nathan Ln N, Plymouth MN 55442-3209
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA