---
title: "EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, wh... — FDA record Z-0149-2023 | Is It on Recall"
description: "Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU."
url: https://isitonrecall.com/recall/fda-device-z-0149-2023-ekos-control-unit-4-0-console-a-component-of-the-ekos-control-system-4-0-which-is-a-component-of-the/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endov... — FDA record Z-0149-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
- **Classification**: Class II
- **Recalling firm**: Boston Scientific Corporation
- **Quantity**: 16 consoles
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0149-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0149-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Serial numbers 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, CU4.0-02146, and CU4.0-02026, UPN 600-40500, GTIN 00858593006462. |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Nov 9, 2022
- **Recall initiation date**: Oct 13, 2022
- **Center classification date**: Oct 28, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0149-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)