Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. |
| 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. |
| Quantity | 16 consoles |
| Distribution | Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong. |
| Initiated | 2022-10-13 |
| Classified | 2022-10-28 |
| Recall number | Z-0149-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-0149-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90984/
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