Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EKOS Control Unit 4.0 console Recalled by Boston Scientific Corporation Due to Consoles were shipped without an instruction for use...
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 Boston Scientific Corporation directly.
Affected Products
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Quantity: 16 consoles
Why Was This Recalled?
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Where Was This Sold?
This product was distributed to 7 states: CA, IL, KY, OH, OK, RI, TX
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report