Device Recall Intrastent Balloon Expandable Biliary Stent

  • Model / Serial
    Lot Number: 2099706
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    ev3 IntraStent Biliary Stent, Model Number: S10-26, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0648-001.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Source
    USFDA

11 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 2709041, 2537571, and 4493725
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000.
  • Manufacturer
  • Model / Serial
    Lot Number: 3604128
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-001.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 2418012, 2703169, and 1688108.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-002. || ev3 IntraStent DoubleStrut Peripheral Stent, Model Number: S11-36, || Catalog Number: 90-1075-002 (not approved within the USA).
  • Manufacturer
  • Model / Serial
    Lot Numbers: 2767839, 2715678, and 2790795
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    ev3 IntraStent LD DoubleStrut || Large Diameter Biliary Stent, Model Number: S15-16, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-1431-000. || ev3 IntraStent LD DoubleStrut || Large Diameter Peripheral Stent, Model Number: S15-16, || Catalog Number: 90-1504-000 (not approved within USA).
  • Manufacturer
  • Model / Serial
    Lot Numbers: 2722702, 2099726, and 1831865
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, || ev3, 4600 Nathan lane North, Plymouth, MN 55442, Catalog Number: 90-1431-002. || ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-36, || Catalog Number: 90-1504-002 (not approved within USA).
  • Manufacturer
6 more