Device Recall IntraAortic Balloon Catheter Mega 8FR 50cc

  • Model / Serial
    0684 00 0296 01U and 0684 00 0296 02U
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Intra-Aortic Balloon Catheter Mega 8FR 50cc || Product Usage: || The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-3206
  • Manufacturer Parent Company (2017)
  • Source
    USFDA