Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz) Recalled by EKOS Corporation Due to The EkoSonic Control Unit is recalled because it...
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 EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. 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.
Quantity: one unit
Why Was This Recalled?
The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
Where Was This Sold?
Worldwide Distribution in Germany only.
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