Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The EKOS EkoSonic Control Unit is intended exclusively for use Recalled by EKOS Corporation Due to The Connector Interface Cable (CIC) was not recognized...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact EKOS Corporation directly.
Affected Products
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.
Quantity: 46 units
Why Was This Recalled?
The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About EKOS Corporation
EKOS Corporation has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report