EKOS Corporation: Medical Device Recall in 2015 - (Recall #: Z-2148-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System 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, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

Product Classification:

Class II

Date Initiated: June 24, 2015

Date Posted: July 29, 2015

Recall Number: Z-2148-2015

Event ID: 71635

Reason for Recall:

The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.

Status: Terminated

Product Quantity: 46 units

Code Information:

CIC Serial Numbers: 19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103, 19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112, 19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118, 19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127, 19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135, 19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144, 19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153, 19598-154, 19598-156, 19598-157, 19598-158.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated