Events

Retiro De Equipo (Recall) de RX ACCULINK Carotid Stent System

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 Abbott Vascular.

¿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
    56973
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0337-2011
  • Fecha de inicio del evento
    2010-09-10
  • Fecha de publicación del evento
    2010-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95083
  • 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
    Stent, carotid - Product Code NIM
  • Causa
    The recall was initiated because abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. if the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.
  • Acción
    Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any unused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter. The consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular. For questions regarding this recall call (951) 914-3324.

Device

RX ACCULINK Carotid Stent System
  • Modelo / Serial
    Lot Number: 0071361
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI
  • Descripción del producto
    RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361 || The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Dirección del fabricante
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • 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