MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA. 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.
Enforcement
- Recall Number
- Z-1405-2020
- Event ID
- 84727
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Microvention, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 4, 2020
- Initiation Date
- November 22, 2019
- Classification Date
- February 27, 2020
- Termination Date
- January 26, 2022
- Address
- 35 Enterprise, N/A, Aliso Viejo, CA, 92656-2601, United States
Description
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA. 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.
The devices may be missing the implant coil.
Catalog/lot numbers: 100102HFRM-V - 1903045W6 and 1903135W6; 100152HFRM-V - 1903085W6, 1903185P6, and 1903185W6; 100153HFRM-V - 1903135W6; 100154HFRM-V - 1903015W6, 1903205W6, 1903225W6, 1904225P6, and 1904225W6; 100202HFRM-V - 1903065W6, 1903085W6, and 1903135W6; 100206HFRM-V - 1903065W6 and 1903085W6; 100208HFRM-V - 1903065W6; 100254HFRM-V - 1903045W6, 1903085W6, and 1903115W6; 100256HFRM-V - 1903045W6 and 1903225W6; 100308HFRM-V - 1903115W6, 1903155W6, and 1903205W6; MV-00202HHTA - 1903065Y6, 1903205Y6, and 1903225Y6; MV-00203HHTA - 1903085Y6, 1903225Y6, 1904155Y6, 1905085X6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00204HHTA - 1903085Y6, 1904155X6, 1904155Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6; MV-00206HHTA - 1904015Y6, 1904155X6, 1905025Y6, 1905035Y6, 1905085Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00208HHTA - 1905135Y6, 1905205Y6, 1905225X6, and 1905225Y6; MV-00304HHTA - 1903065Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1905025Y6, 1905065Y6, and 1905085Y6; MV-00306HHTA - 1903135Y6, 1903205Y6, 1903225Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, and 1905135Y6; MV-00308HHTA - 1905085Y6, 1905205Y6, and 1905225Y6; MV-00310HHTA - 1905025Y6, 1905035Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00408HHTA - 1903225X6, 1904035Y6, 1905025Y6, and 1905035Y6; MV-00412HHTA - 1903115Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1904225Y6, 1905025Y6, 1905035Y6, 1905065Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905175Y6, and 1905205Y6; MV-00510HHTA - 1903225Y6, 1904035Y6, 1904055Y6, 1905085Y6, 1905105Y6, 1905175Y6, and 1905225Y6; MV-00515HHTA - 1903225X6, 1904035Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905175X6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00612HHTA - 1903085Y6, 1903115Y6, 1903135Y6, 1903225X6, 1904055Y6, 1905025Y6, 1905035Y6, and 1905085Y6; MV-00619HHTA - 1903085Y6, 1903115Y6, 1903225Y6, 1904055Y6, 1905035Y6, 1905065Y6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00715HHTA - 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, 1905225X6, and 1905225Y6; MV-00728HHTA - 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00817HHTA - 1905105Y6, 1905175Y6, and 1905205X6; MV-00833HHTA - 1903085Y6, 1903205Y6, 1905035Y6, 1905085Y6, 1905135Y6, and 1905205Y6; MV-01502HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905105Y6, 1905175Y6, and 1905205Y6; MV-01503HHTA - 1903085Y6, 1903115Y6, 1903135Y6, 1903205Y6, 1903225X6, 1903225Y6, 1904035Y6, and 1905035Y6; MV-01504HHTA - 1905035Y6, 1905065Y6, and 1905085Y6; MV-02504HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905065Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-02506HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6; and MV-02508HHTA - 1905085Y6, 1905105Y6, 1905135Y6, 1905155Y6, 1905205Y6, and 1905225Y6.
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.
847 units