Device Recall EKOS EkoSonic Endovascular Device

Lot Number 150910004. Expiration date is August 15, 2018.  Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010

Cardiovascular Devices

2

No

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

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.