Terumo AZUR Peripheral Coil System — Class II medical device recall Z-1223-2020
Terminated recall by Microvention, Inc., reported 2020-02-19, distributed in MD. The devices may be missing the implant coil.
| Recall number | Z-1223-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microvention, Inc., Aliso Viejo, CA, United States |
| Recall initiated | 2019-11-24 |
| Classified | 2020-02-13 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2021-04-20 |
| Distributed | MD |
| Countries outside the US | AR, AU, BE, JP, MX |
| Quantity | 392 units |
| Lot numbers | 19030453C, 19030453J, 19030453K, 19030456B, 19030456C, 19030456E, 19030456F, 19030456G, 19030456H, 19030456J, 19030456L, 19030456N, 19030654L, 19030654N, 19030654R, 19030654U, 19030654W, 19030655G, 19030655H, 19030655N, 19030655V, 19030655W, 190401568, 190405564, 19040853N, 190408565, 190408569, 19040856A, 190410568, 190410569, 19041056A, 19041056C, 190410588, 190410589, 19041058A, 19041058C, 19041058E, 19041058F, 19041552H, 19041554R and 39 more |
| Model numbers | 45-450405, 45-450410, 45-450415, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, MV-AZ52030HD |
Product
Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
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-1223-2020. 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.