Events

Retiro De Equipo (Recall) de Device Recall 1500T9 Cardiac Ablation Generator

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 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
    60996
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1032-2012
  • Fecha de inicio del evento
    2012-01-05
  • Fecha de publicación del evento
    2012-02-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107008
  • 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
    Two st jude medical 1500t9 rf generator units were distributed to customers while still under fda review as part of a pma supplement to the approved pma applications.
  • Acción
    The notification letter was dated January 5th, 2012 and titled "Product Recall RF Generator 1500T9-CP". The letter informed customers that a St Jude Medical 1500T9-CP RF Generator unit had been distributed to them while currently under FDA review as part of a PMA supplement application. The letter requested that the use of the impacted generator be discontinued. Customers were requested to return the field action form and return the unit identified in the letter. The contact number provided in the letter is: 651-756-2000.

Device

Device Recall 1500T9 Cardiac Ablation Generator
  • Modelo / Serial
    T9 Generator - Catalog 1500T9/Model IBI-89000. Serial numbers: 13826729 and 13827596.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution, including the states of Kansas and Maryland.
  • Descripción del producto
    The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter.
  • Manufacturer
    St Jude Medical Inc

Manufacturer

St Jude Medical Inc
  • Dirección del fabricante
    St Jude Medical Inc, 177 E County Road B, Saint Paul MN 55117-1951
  • 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