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Terminated

EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

FDA Recall Z-0864-2016 · Posted 2016-02-24

Recalling FirmEKOS Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2016-01-21
Date Terminated2016-03-15
Product Quantity10 units

Reason for Recall

The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.

Firm Action

All affected consignees were contacted by telephone January 20- 22, 2016. The URGENT VOLUNTARY PRODUCT RECALL letter, dated January 21, 2016, was sent to consignees. Consignees were advised that replacement devices were shipped to their facility on January 21, 2016 and should arrive there on January 22, 2016. Consignees with questions can call: Jocelyn Kersten Vice President, Regulatory and Clinical Affairs EKOS Corporation, a BTG International Group Company 425-415-3132 [email protected]

Root Cause

Error in labeling

Distribution Pattern

Distributed in the states of AZ, CA, MA, MI, OH, and VA.

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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