EKOS Control Unit 4 — Class II medical device recall Z-0149-2023
Ongoing recall by Boston Scientific Corporation, reported 2022-11-09, distributed in CA, IL, KY, OH, OK, RI, TX. Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
| Recall number | Z-0149-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2022-10-13 |
| Classified | 2022-10-28 |
| Reported by FDA | 2022-11-09 |
| Distributed | CA, IL, KY, OH, OK, RI, TX |
| Countries outside the US | CL, HK |
| Quantity | 16 consoles |
| UPC / GTIN / UDI-DI | 00858593006462 |
| Serial numbers | 600-40500, CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804, CU4.0-01835, CU4.0-01840, CU4.0-01843, CU4.0-01897, CU4.0-01980, CU4.0-02022, CU4.0-02026, CU4.0-02146 |
Product
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Reason for recall
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
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-0149-2023. 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.