Events

Retiro De Equipo (Recall) de THORATEC 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 Corp.

¿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
    50091
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0496-2009
  • Fecha de inicio del evento
    2008-10-24
  • Fecha de publicación del evento
    2008-12-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74710
  • 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 (assist) bypass - Product Code DSQ
  • Causa
    The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the heartmate ii left ventricular assist system (hm ii lvas) blood pump with external system controller may result in damage that has the potential to interrupt pump function and may require a reoperation to replace the pump.
  • Acción
    An initial "Urgent: Medical Device Correction" letter dated October 21, 2008 and a follow-up letter dated October 24, 2008 were sent to affected HeartMate II Left Ventricular Assist System (HM II LVAS) customers. The letters identified the problem, immediate action and preventive action to be taken by customers and recommended that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. If customers suspect that a HM II LVAS patient may have a damaged percutaneous lead, please contact Thoratec Technical Services (800-456-1477) for assistance. A return response (Acknowledgement Form) was included with the letter for consignees to complete and fax it to Thoratec Regulatory Affairs at 925-847-8628. Direct questions to the Thoratec Regulatory Affairs Department at 925-730-4135 (Monday-Friday, 8 a.m.-5 p.m. PST). Clinicians and patients with questions may contact the firm at 800-528-2577, or if calling outside the USA, 925-847-8600 (7 days a week, 8 a.m.-5 p.m. PST). Copies of the press release may be found on the firm's website, www.thoratec.com, under Investor Relations/Press Releases.

Device

THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
  • Modelo / Serial
    All serial numbers.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. || Product is manufactured and distributed by Thoratec Corporation, || Pleasant, CA. || 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 transplantation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital.
  • Manufacturer
    Thoratec Corp

Manufacturer

Thoratec Corp
  • Dirección del fabricante
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588
  • Source
    USFDA