EkoSonic Endovascular System recalled over sterility concerns

Recall date

January 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

EKOS Corporation recalls EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic End…

Recall number

Z-0864-2016

FDA classification

Class II

Brand / firm

EKOS Corporation

Sold / distributed

Distributed in the states of AZ, CA, MA, MI, OH, and VA.

Why it was recalled

The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.