EKOS Corporation: Medical Device Recall in 2016 - (Recall #: Z-0864-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 21, 2016

Date Posted: March 2, 2016

Recall Number: Z-0864-2016

Event ID: 73195

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated