Device Recall Percutaneous Insertion Tray

  • Modelo / Serial
    Batch: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
  • Descripción del producto
    Percutaneous Insertion Tray; Product Code: IAK-S7IT || The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
  • Manufacturer
  • 2 Event

Fabricante

  • Dirección del fabricante
    Arrow International, Inc., Division of Teleflex Medical Inc., 9 Plymouth St, Everett MA 02149-1814
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA