FDAFDA · Alimentos y medicamentos·N.º oficial Z-1471-2014
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.
Publicado el 30 de abril de 2014 · Inicio del retiro: 6 de diciembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- HeartWare Inc
- Distribuidor
- 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.
- Lote
- Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW11270 and HW20001 to HW 20296.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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