FDAFDA · Alimentos y medicamentos·N.º oficial Z-1538-2017
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated 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 Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Publicado el 3 de mayo de 2017 · Inicio del retiro: 3 de febrero de 2017
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Heartware
- Distribuidor
- Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, , Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, UK, and Vietnam.
- Lote
- HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435 .
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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