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Terminated

EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter

FDA Recall Z-2854-2016 · Posted None

Recalling FirmEKOS Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2016-08-09
Date Terminated2016-10-05
Product Quantity10 units

Reason for Recall

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.

Firm Action

All affected consignees were contacted by e-mail on August 9, 2016, and asked to sequester implicated devices.

Root Cause

Storage

Distribution Pattern

Three international consignees - Germany, New Zealand and Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111705EKOSONIC ENDOVASCULAR SYSTEMEkos Corporation · 2011-08-03K081467EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATIONEkos Corp. · 2008-06-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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