Class 2 Device Recall EKOS EkoSonic Endovascular System

• Date Initiated by Firm: June 24, 2015
• Date Posted: July 20, 2015
• Recall Status: Terminated on August 25, 2015
• Recall Number: Z-2148-2015
• Recall Event ID: 71635
• 510(K)Number: K081467 K111705 K140151
• Product Classification: Catheter, continuous flush - Product Code KRA
• Product: The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device.; ; The EkoSonic Endovascular System 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, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
• Code Information: CIC Serial Numbers: 19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103, 19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112, 19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118, 19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127, 19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135, 19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144, 19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153, 19598-154, 19598-156, 19598-157, 19598-158.
• Recalling Firm/ Manufacturer: EKOS Corporation; 11911 N Creek Pkwy S; Bothell WA 98011-8809
• For Additional Information Contact: Jocelyn Kersten; 425-415-3132
• Manufacturer Reason for Recall: The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
• FDA Determined Cause: Vendor change control
• Action: Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer. The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment. Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter. Customers with questions can contact EKOS Customer Service at 1-888-400-3567.
• Quantity in Commerce: 46 units
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KRA and Original Applicant = BTG INTERNATIONAL, INC.; 510(K)s with Product Code = KRA and Original Applicant = EKOS CORP.; 510(K)s with Product Code = KRA and Original Applicant = EKOS CORPORATION