Device Recall Intrastent Balloon Expandable Biliary Stent

Lot Numbers: 2709041, 2537571, and 4493725

Gastroenterology-Urology Devices

2

Yes

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.

ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000.

Lot Number: 3604128

Gastroenterology-Urology Devices

2

Yes

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.

ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-001.

Lot Numbers: 2418012, 2703169, and 1688108.

Gastroenterology-Urology Devices

2

Yes

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.

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).

Lot Numbers: 2767839, 2715678, and 2790795

Gastroenterology-Urology Devices

2

Yes

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.

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).

Lot Numbers: 2722702, 2099726, and 1831865

Gastroenterology-Urology Devices

2

Yes

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.

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).