Reported Mar 4, 2020 · Terminated
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers…
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 HydroFrame 18HydroCoil Embolic SystemEndovascular Embolization CoilSterileRxREF numbers 180723HFRM-V180931HFRM-V181644HFRM-VMV-80619HHFAMV80827HHFAMV-80931HHFAand MV-81036HHFA
- 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
- Catalog/lot numbers
180723HFRM-V - 1904175P7 and 1904175W7180931HFRM-V - 1904225P7 and 1904225W7181644HFRM-V - 1905025W7 and 1905155W7MV-80619HHFA - 1904175X71904175Y71905065X7and 1905085Y7MV-80827HHFA - 1904175X71904225Y7and 1905065X7MV-80931HHFA - 1905065X7and MV-81036HHFA - 1904175Y7
- Catalog/lot numbers
- Amount recalled
- 32 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.
Want the full recall guide?
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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