Devices

Device Recall AB5000 Portable Driver

  • Modelo / Serial
    Serial numbers: AF0013 - AF0015, AF0017, AF0018, AF0020, AF0022-AF0024, AF0028, AF0030, AF0037, AF0038, AF0043, AF0049, and AF0053 - AF0055.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.
  • Descripción del producto
    Abiomed AB5000 Portable Driver || Catalog number: 0025-0000 || The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.
  • Manufacturer
    Abiomed, Inc.
  • 1 Event

Fabricante

Abiomed, Inc.
  • Dirección del fabricante
    Abiomed, Inc., 22 Cherry Hill Dr, Danvers MA 01923
  • Empresa matriz del fabricante (2017)
    Abiomed, Inc.
  • Source
    USFDA