Device Recall ATS Mechanical Heart Valve

  • Model / Serial
    500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide throughout the US and worldwide.
  • Product Description
    ATS Open Pivot Mechanical Heart Valve
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    ATS Medical, Inc., 3905 Annapolis Ln N Ste 105, Minneapolis MN 55447-5473
  • Source
    USFDA