Microvention, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1403-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 22, 2019

Date Posted: March 4, 2020

Recall Number: Z-1403-2020

Event ID: 84727

Reason for Recall:

The devices may be missing the implant coil.

Status: Terminated

Product Quantity: 32 units

Code Information:

Catalog/lot numbers: 180723HFRM-V - 1904175P7 and 1904175W7; 180931HFRM-V - 1904225P7 and 1904225W7; 181644HFRM-V - 1905025W7 and 1905155W7; MV-80619HHFA - 1904175X7, 1904175Y7,1905065X7, and 1905085Y7; MV-80827HHFA - 1904175X7, 1904225Y7, and 1905065X7; MV-80931HHFA - 1905065X7; and MV-81036HHFA - 1904175Y7.

Distribution Pattern:

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated