Reported Mar 4, 2020 · Terminated
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx,…
Microvention, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microvention, Inc. · 35 Enterprise · Aliso Viejo, CA · 92656-2601
Is this the product you have?
MicroVention Terumo HydroSoft 10HydroCoil Embolic SystemEndovascular Embolization CoilHydroSoft 3DSterileRxREF numbers 100102HFRM-V100152HFRM-V100153HFRM-V100154HFRM-V100202HFRM-V100206HFRM-V100208HFRM-V100254HFRM-V100256HFRM-V100308HFRM-VMV-00202HHTAMV-00203HHTAMV-00204HHTAMV-00206HHTAMV-00208HHTAMV-00304HHTAMV-00306HHTAMV-00308HHTAMV-00310HHTAMV-00408HHTAMV-00412HHTAMV-00510HHTAMV-00515HHTAMV-00612HHTAMV-00619HHTAMV-00715HHTAMV-00728HHTAMV-00817HHTAMV-00833HHTAMV-01502HHTAMV-01503HHTAMV-01504HHTAMV-02504HHTAMV-02506HHTAand MV-02508HHTA
- Product UsageThe 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
- Lot codes and dates
35 of 35 products
Products covered by this recall # Product as published 1 100102HFRM-V - 1903045W6 and 1903135W6 2 100152HFRM-V - 1903085W6, 1903185P6, and 1903185W6 3 100153HFRM-V - 1903135W6 4 100154HFRM-V - 1903015W6, 1903205W6, 1903225W6, 1904225P6, and 1904225W6 5 100202HFRM-V - 1903065W6, 1903085W6, and 1903135W6 6 100206HFRM-V - 1903065W6 and 1903085W6 7 100208HFRM-V - 1903065W6 8 100254HFRM-V - 1903045W6, 1903085W6, and 1903115W6 9 100256HFRM-V - 1903045W6 and 1903225W6 10 100308HFRM-V - 1903115W6, 1903155W6, and 1903205W6 11 MV-00202HHTA - 1903065Y6, 1903205Y6, and 1903225Y6 12 MV-00203HHTA - 1903085Y6, 1903225Y6, 1904155Y6, 1905085X6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6 13 MV-00204HHTA - 1903085Y6, 1904155X6, 1904155Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6 14 MV-00206HHTA - 1904015Y6, 1904155X6, 1905025Y6, 1905035Y6, 1905085Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6 15 MV-00208HHTA - 1905135Y6, 1905205Y6, 1905225X6, and 1905225Y6 16 MV-00304HHTA - 1903065Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1905025Y6, 1905065Y6, and 1905085Y6 17 MV-00306HHTA - 1903135Y6, 1903205Y6, 1903225Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, and 1905135Y6 18 MV-00308HHTA - 1905085Y6, 1905205Y6, and 1905225Y6 19 MV-00310HHTA - 1905025Y6, 1905035Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6 20 MV-00408HHTA - 1903225X6, 1904035Y6, 1905025Y6, and 1905035Y6 - Amount recalled
- 847 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
The devices may be missing the implant coil.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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