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U.S. Department of Health and Human Services

Class 2 Device Recall EKOS EkoSonic Endovascular Device

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  Class 2 Device Recall EKOS EkoSonic Endovascular Device see related information
Date Initiated by Firm January 21, 2016
Date Posted February 24, 2016
Recall Status1 Terminated 3 on March 15, 2016
Recall Number Z-0864-2016
Recall Event ID 73195
510(K)Number K081467  K111705  K140151  
Product Classification Catheter, continuous flush - Product Code KRA
Product 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.
Code Information Lot Number 150910004. Expiration date is August 15, 2018.  Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
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 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.
FDA Determined
Cause 2		 Error in labeling
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 Jocelyn.kersten@ekoscorp.com
Quantity in Commerce 10 units
Distribution Distributed in the states of AZ, CA, MA, MI, OH, and VA.
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
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