MicroVention Terumo Microplex 18 — Class II medical device recall Z-1399-2020
Terminated recall by Microvention, Inc., reported 2020-03-04, distributed in GA. The devices may be missing the implant coil.
| Recall number | Z-1399-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microvention, Inc., Aliso Viejo, CA, United States |
| Recall initiated | 2019-11-22 |
| Classified | 2020-02-27 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2022-01-26 |
| Distributed | GA |
| Countries outside the US | AE, AT, BE, BG, BR, CH, CN, CY, CZ, DE, DK, EG, ES, FR, GB, IE, IL, IT, JO, JP, KR, LB, LV, MA, MT, NL, NO, PL, PT, RO, RS, SE, SI, TR, UA, ZA |
| Quantity | 403 units |
| Lot numbers | 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, 182468CS-V, 1903015L1, 1903015W1, 1903045L1, 1903045W1, 1903065W1, 1903085P1, 1903085V1, 1903085W1, 1903135R1, 1903155P1, 1903155W1, 1903185H1, 1903185W1, 1903205H1, 1903205P1, 1903205W1, 1903225W1, 1904015P1, 1904035R1, 1904055R1, 1904085Q1, 1904105W1, 1904175P1, 1904225R1, 1904225W1, 1904245P1 and 21 more |
| Model numbers | 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, 182468CS-V |
Product
MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-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 for recall
The devices may be missing the implant coil.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1399-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.