Events

Retiro De Equipo (Recall) de HeartWare Ventricular Assist System (HVAD)

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 HeartWare 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
    71240
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1917-2015
  • Fecha de inicio del evento
    2015-04-29
  • Fecha de publicación del evento
    2015-06-26
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136957
  • 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
    Complaints with the hvad abnormal power source switching.
  • Acción
    HeartWare sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the enclosed Patient Communication and familiarize the contents, forward the notice to those individuals withing their organization who need to be aware of its contents, identify their patients currently supported by the HVAD System, distribute the Patient Communication to their patients via FedEX or some other reliable means of communication. Customers with questions were instructed to contact their HeartWare representative should they need any assistance with the process. Customers were asked to complete, sign, and return the Acknowledgement and Completion Form to HeartWare. Customers with quesitons were instructed to call 1-888-494-6365.

Device

HeartWare Ventricular Assist System (HVAD)
  • Modelo / Serial
    Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
  • Descripción del producto
    HeartWare Ventricular Assist System (HVAD) || For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
  • Manufacturer
    HeartWare Inc

Manufacturer

HeartWare Inc
  • Dirección del fabricante
    HeartWare Inc, 14400 Nw 60th Ave, Miami Lakes FL 33014-2807
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA