FDA Device recall Z-1404-2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V,…
- FDA Device
- Class II
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V,… by Microvention, citing the devices may be missing the implant coil.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1404-2020 |
| 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 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-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: 100203CMSR-V - 1903085WP; 100408CMSR-V - 1903085WP and 1904015PP; 100412CMSR-V - 1904225R…Catalog/lot numbers: 100203CMSR-V - 1903085WP; 100408CMSR-V - 1903085WP and 1904015PP; 100412CMSR-V - 1904225RP, 1905205QP, and 1904035PP; 100510CMSR-V - 1905205QP and 1904085WP; 100516CMSR-V - 1903135WP and 1905155WP; 100612CMSR-V - 1903225WP; 100618CMSR-V - 1903135QP and 1904085WP; and 100721CMSR-V - 1903085RP. |
|---|
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-1404-2020%22
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