MicroVention Terumo HydroSoft 10 — Class II medical device recall Z-1405-2020
Terminated recall by Microvention, Inc., reported 2020-03-04, distributed in GA. The devices may be missing the implant coil.
| Recall number | Z-1405-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microvention, Inc., Aliso Viejo, CA, United States |
| Recall initiated | 2019-11-22 |
| Classified | 2020-02-27 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2022-01-26 |
| Distributed | GA |
| Countries outside the US | AE, AT, BE, BG, BR, CH, CN, CY, CZ, DE, DK, EG, ES, FR, GB, IE, IL, IT, JO, JP, KR, LB, LV, MA, MT, NL, NO, PL, PT, RO, RS, SE, SI, TR, UA, ZA |
| Quantity | 847 units |
| Lot numbers | 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, 1903015W6, 1903045W6, 1903065W6, 1903065Y6, 1903085W6, 1903085Y6, 1903115W6, 1903115Y6, 1903135W6, 1903135Y6, 1903155W6, 1903185P6, 1903185W6, 1903205W6, 1903205Y6, 1903225W6, 1903225X6, 1903225Y6, 1904015Y6, 1904035Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1904155X6, 1904155Y6, 1904225P6, 1904225W6, 1904225Y6, 1905025Y6, 1905035Y6 and 37 more |
| Model 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 and 10 more |
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 for recall
The devices may be missing the implant coil.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1405-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.