Device Recall Circulatory Support System

  • Modèle / numéro de série
    Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
  • Description du dispositif
    Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. || Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.
  • Manufacturer
  • 1 Event

Fabricant

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