EKOS Corporation recalls EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter

Recall date

August 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2854-2016

FDA classification

Class II

Brand / firm

EKOS Corporation

Sold / distributed

Three international consignees - Germany, New Zealand and Taiwan

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter