Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter Recalled by EKOS Corporation Due to The recalling firm identified ten devices which were...
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
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Quantity: 10 units
Why Was This Recalled?
The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
Where Was This Sold?
Three international consignees - Germany, New Zealand and Taiwan
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