# FDA recall Z-0637-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-11-03.

## Product

EKOS Control System (CU) 4.0. UPN 600-40500      The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control.  A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.

## Reason for recall

This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.

## Distribution

No US distribution. Foreign distribution to Latin America and EU.

## Key facts

- **Recall number:** Z-0637-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-03
- **Report date:** 2020-12-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0637-2021

## Citation

> AI Analytics. FDA recall Z-0637-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0637-2021. Source: US FDA. Licensed CC0.

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