MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Detalles del retiro

Fabricante

Microvention, Inc.

Distribuidor

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

Lote

Catalog/lot numbers: 180723HFRM-V - 1904175P7 and 1904175W7; 180931HFRM-V - 1904225P7 and 1904225W7; 181644HFRM-V - 1905025W7 and 1905155W7; MV-80619HHFA - 1904175X7, 1904175Y7,1905065X7, and 1905085Y7; MV-80827HHFA - 1904175X7, 1904225Y7, and 1905065X7; MV-80931HHFA - 1905065X7; and MV-81036HHFA - 1904175Y7.

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States