Events

Retiro De Equipo (Recall) de Device Recall Heartware HVAD Pump Implant Kit

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
    67466
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1471-2014
  • Fecha de inicio del evento
    2013-12-06
  • Fecha de publicación del evento
    2014-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125510
  • 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
    The housing to the pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
  • Acción
    HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their hospitals and doctors on December 12, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. For already implanted patients, arrange a follow up visit at the earliest convenience to check patient's driveline connector. They were asked to sign and return the Acknowledgement Form to HeartWare. For questions, contact your HeartWare Representative or HeartWare Customer Service at 1-877-367-4823.

Device

Device Recall Heartware HVAD Pump Implant Kit
  • Modelo / Serial
    Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW11270 and HW20001 to HW 20296.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
  • 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