Device Recall AMS 800 Urinary Control System Control Pump

  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution--USA (nationwide) including Washington D.C. and Puerto Rico and the countries FRANCE, GERMANY, CANADA, ISRAEL, SOUTH AFRICA, LEBANON, AUSTRIA, ARGENTINA, SAUDI ARABIA, SPAIN, BELGIUM NETHERLANDS, PERU, VENEZUELA, SRI LANKA, PORTUGAL, TUKEY, BRAZIL AUSTRALIA, CZECH REPUBLIC, TUNISIA. LUXWMBOURG, QATAR, SOLOMON ISLANDS, BOSNIA & HERZEGOVIA, CHILE, CHINA, COLOMBIA, COSTA RICA, DENMARK, ECUADOR, ESTONIA, FINLAND, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, POLND, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SLOVENIA, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM and URUGUAY.
  • Product Description
    AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343 || InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO, American Medical Systems Inc., 10700 Bren West, Minnetonka, MN 55343 || The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    American Medical Systems, Inc., 10700 Bren Road West, Minnetonka MN 55343-9679
  • Source
    USFDA