# FDA recall Z-0149-2023

> **Boston Scientific Corporation** · Class II · device recall initiated 2022-10-13.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0149-2023
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-13
- **Report date:** 2022-11-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0149-2023

## Citation

> AI Analytics. FDA recall Z-0149-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0149-2023. Source: US FDA. Licensed CC0.

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