FDA Device recall Z-1405-2020
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HF…
- FDA Device
- Class II
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HF… by Microvention, citing the devices may be missing the implant coil.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1405-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-22 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Microvention |
| Distribution | GA |
Product
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.
Reason
The devices may be missing the implant coil.
Identifiers
| code_info | Catalog/lot numbers: 100102HFRM-V - 1903045W6 and 1903135W6; 100152HFRM-V - 1903085W6, 1903185P6, and 1903185W6;…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 - 1903 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1405-2020%22
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