Events

Retiro De Equipo (Recall) de Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly

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 Cardiac Assist, 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
    57414
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0889-2011
  • Fecha de inicio del evento
    2010-12-02
  • Fecha de publicación del evento
    2011-01-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96093
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    Component (dilator of tandemheart transseptal cannula set-ef) does not meet specifications.
  • Acción
    CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed "CAUTION: DO NOT USE" sticker(s) and quarantine to prevent usage. Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product. For questions regarding this recall call (412) 963-7770, ext. 271.

Device

Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly
  • Modelo / Serial
    Part number 5140-6221 - Lot numbers 2010060684 & 2010071887
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
  • Descripción del producto
    TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly || The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
  • Manufacturer
    Cardiac Assist, Inc

Manufacturer

Cardiac Assist, Inc
  • Dirección del fabricante
    Cardiac Assist, Inc, 240 Alpha Dr, Pittsburgh PA 15238-2906
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    USFDA