Device Recall Impella 5.0 Circulatory Support System

  • Modèle / numéro de série
    Serial numbers: 45921,45922,45923,45924
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International only: Canada and France
  • Description du dispositif
    Impella 5.0 Circulatory Support System || Catalog number: 004840 || The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abiomed, Inc., 22 Cherry Hill Dr, Danvers MA 01923
  • Société-mère du fabricant (2017)
  • Source
    USFDA