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EKOS Corporation recalls EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Recalled September 28, 2016 · FDA recall Z-2854-2016 · EKOS
Hazard
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. · FDA Class II
Units
10 units
Sold at
Three international consignees - Germany, New Zealand and Taiwan
Description
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.
Product
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Manufacturer(s)
EKOS Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →