Events

Retiro De Equipo (Recall) de Device Recall HeartMate II Left Ventricular Assist 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 Thoratec Corporation.

¿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
    61268
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1228-2012
  • Fecha de inicio del evento
    2012-02-23
  • Fecha de publicación del evento
    2012-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107693
  • 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
    Ventricular (assisst) bypass - Product Code DSQ
  • Causa
    A trend of disconnected bend reliefs on the sealed outflow graft used with the heartmate ii lvas has been identified.
  • Acción
    Thoractec Corporation sent an Urgent Medical Device Correction letter on February 23, 2012 via overnight courier and e-mail to all affected consignees. The Urgent Medical Device Correction notification letters identify the affected products, description of the problem with illustrations, symptoms of problem and immediate actions to taken. All users are asked to review the attached labeling, including new caution statements and share with all surgical personnel. Consignees are instructed to completed and returned the Acknowledgement Form indicating that the information was received and understood. Additionally, an update concerning the Worldwide Medical Device Correction Notification is enclosed with each letter. Questions should be directed to Thoratec Regulatory Affairs at 925-847-8571.

Device

Device Recall HeartMate II Left Ventricular Assist System
  • Modelo / Serial
    Sealed Outflow Graft: Catalog number 103393, all lot numbers; Sealed Outflow Short Bend Relief; Catalog number 104692, all lot numbers; Catalog number 104911, HM II LVAS Implant Kit (with sealed grafts) [US labeling] (contains catalog number 103393); all serial numbers; Catalog number 104912, HM II LVAS Implant Kit (with sealed grafts) [CE Mark labeling], contains catalog no. 103393); all serial numbers:
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Denmark, Germany, Greece, France, Hong Kong, Kuwait, Ireland, Israel, Italy, Lebanon, Liechtenstein, Lithuania, Luxembourg, Malaysia, Netherlands, Turkey, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand and United Kingdom.
  • Descripción del producto
    HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. || The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in turn is a component of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM II LVAS Sealed Outflow Graft Bend Relief is provided as a stand-along product. || Thoratec Corporation || 6035 Stoneridge Drive || Pleasanton, CA 94588. || Product Usage: || The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to Cardiac Transplanation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital. The outflow of the HM II LVAS blood pump is connected to the aorta with a flexible vascular graft. The outflow graft is provided with a bend relief, a three or four in long tube of reinforced ePTFE surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft.
  • Manufacturer
    Thoratec Corporation

Manufacturer

Thoratec Corporation
  • Dirección del fabricante
    Thoratec Corporation, 6035 Stoneridge Dr, Pleasanton CA 94588-3270
  • 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