MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular ...



MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. 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.
Components:
Recall Date:    Nov 22, 2019
Mfg:
Microvention, Inc.
Mfg Country:
United States
Recall ID:    84727
Product ID:    179473
Enforcement Date:    Mar 4, 2020
Last Published:    Feb 27, 2020

__________

Emert Number:    Z-1403-2020
Emert Status:    Announced