Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-0149-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.

Product Classification:

Class II

Date Initiated: October 13, 2022

Date Posted: November 9, 2022

Recall Number: Z-0149-2023

Event ID: 90984

Reason for Recall:

Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

Status: Ongoing

Product Quantity: 16 consoles

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated