Device Recall Percutaneous Insertion Tray

  • Model / Serial
    Batch: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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).
  • Product Description
    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 Events

Manufacturer

  • Manufacturer Address
    Arrow International, Inc., Division of Teleflex Medical Inc., 9 Plymouth St, Everett MA 02149-1814
  • Manufacturer Parent Company (2017)
  • Source
    USFDA