FDA Device recall Z-1406-2020
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC…
- FDA Device
- Class II
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC… by Microvention, citing the devices may be missing the implant coil.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1406-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-22 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Microvention |
| Distribution | GA |
Product
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.
Reason
The devices may be missing the implant coil.
Identifiers
| code_info | Catalog/lot numbers: MV-00306VFC - 1904105NZ and 1905085NZ; MV-00310VFC - 1903045TZ, 1904035TZ, 1904085NZ, AND 19…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, 19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1406-2020%22
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