Microvention, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1406-2020)

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 Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC152040-V, and VFC152060-V. Product Usage: . The MCS 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-1406-2020
Event ID: 84727
Reason for Recall:

The devices may be missing the implant coil.

Status: Terminated
Product Quantity: 666 units
Code Information:

Catalog/lot numbers: MV-00306VFC - 1904105NZ and 1905085NZ; MV-00310VFC - 1903045TZ, 1904035TZ, 1904085NZ, AND 1905065NZ; MV-00315VFC - 1903045TZ, 1903155NZ, and 1904055YV; MV-00630VFC - 1904085FV and 1905085FV; VFC010303-V - 1903065WV, 1904015WV, 1904105WV, 1904155WV, 1904175WV, 1904225WV, 1904245WV, 1904265WV, 1905065WV, 1905105WV, 1905155WV, and 1905175WV; VFC030606-V - 1903045WV, 1903065WV, 1903085PV, 1903205WV, 1904015WV, 1904035WV, 1904055WV, 1904105WV, 1904155PV, 1904175UV, 1904175WV, 1904225WV, 1904245UV, 1904245WV, 1904265WV, 1905065WV, and 1905175WV; VFC030610-V - 1903015WV, 1903065WV, 1904015WV, 1904035WV, 1904055WV, 1904155WV, 1904175UV, 1904175WV, 1904225UV, 1904225WV, 1904245UV, 1904245WV, 1904265WV, 1905065WV, 1905085WV, 1905105WV, 1905135WV, 1905155PV, 1905175WV, and 1905225WV; VFC030615-V - 1903015WV, 1903045WV, 1903065PV, 1903065WV, 1903225UV, 1903225ZV, 1904015WV, 1904055WV, 1904085WV, 1904245WV, 1904265WV, 1905025WV, 1905035WV, 1905085PV, 1905085WV, and 1905175WV; VFC061020-V - 1903045WV, 1903065WV, 1903205WV, 1904225WV, 1904265WV, 1905025WV, 1905065WV, 1905085WV 1905175WV, and 1905225WV; VFC061030-V - 1903065WV, 1904015PV, 1904015WV, 1904055WV, 1904225WV, 1904245WV, 1904265WV, 1905035WV, 1905065PV, and 1903115RV; VFC101530-V - 1903135WV, 1904265WV, 1905025WV, 1905105WV, 1905175WV, and 1905205WV; VFC101540-V - 1903045WV, 1903185WV, 1904265WV, 1905025WV, 1905035WV, and 1905225WV; VFC152040-V - 1903135RV; and VFC152060-V - 1903085RV, 1904265RV, and 1905135RV.

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