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U.S. Department of Health and Human Services

Class 2 Device Recall EKOS Control System

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  Class 2 Device Recall EKOS Control System see related information
Date Initiated by Firm November 03, 2020
Create Date December 17, 2020
Recall Status1 Open3, Classified
Recall Number Z-0637-2021
Recall Event ID 86847
510(K)Number K183361  
Product Classification Catheter, continuous flush - Product Code KRA
Product EKOS Control System (CU) 4.0. UPN 600-40500


The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.
Code Information Serial numbers CU4.0-01062 CU4.0-01063 CU4.0-01066 CU4.0-01068 CU4.0-01069 CU4.0-01070 CU4.0-01072 CU4.0-01073 CU4.0-01074 CU4.0-01076 CU4.0-01078 CU4.0-01079 CU4.0-01081 CU4.0-01083 CU4.0-01084 CU4.0-01086 CU4.0-01088 CU4.0-01089 CU4.0-01090 CU4.0-01091 CU4.0-01093 CU4.0-01094 CU4.0-01095 CU4.0-01096 CU4.0-01097 CU4.0-01100 CU4.0-01101 CU4.0-01102 CU4.0-01103 CU4.0-01104 CU4.0-01106 CU4.0-01107 CU4.0-01108 CU4.0-01110 CU4.0-01113 CU4.0-01114 CU4.0-01115 CU4.0-01116 CU4.0-01117 CU4.0-01119 CU4.0-01121 CU4.0-01123 CU4.0-01124 CU4.0-01126 CU4.0-01127 CU4.0-01128 CU4.0-01129 CU4.0-01130 CU4.0-01131 CU4.0-01132 CU4.0-01133 CU4.0-01134 CU4.0-01135 CU4.0-01138 CU4.0-01141 CU4.0-01142 CU4.0-01143 CU4.0-01144 CU4.0-01146 CU4.0-01147 CU4.0-01149 CU4.0-01151 CU4.0-01152 CU4.0-01153 CU4.0-01154 CU4.0-01157 CU4.0-01158 CU4.0-01159 CU4.0-01160 CU4.0-01161 CU4.0-01162 CU4.0-01163 CU4.0-01164 CU4.0-01165 CU4.0-01166 CU4.0-01167 CU4.0-01170 CU4.0-01173 CU4.0-01174 CU4.0-01175 CU4.0-01176 CU4.0-01177 CU4.0-01178 CU4.0-01179 CU4.0-01185 CU4.0-01186 CU4.0-01191 CU4.0-01195 CU4.0-01198 CU4.0-01203 CU4.0-01205 CU4.0-01215 CU4.0-01231 CU4.0-01233 CU4.0-01234 CU4.0-01237 CU4.0-01239 CU4.0-01245 CU4.0-01248 CU4.0-01251 CU4.0-01252 CU4.0-01255 CU4.0-01268 CU4.0-01289 CU4.0-01292 CU4.0-01299 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
508-683-4000
Manufacturer Reason
for Recall		 This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.
FDA Determined
Cause 2		 Device Design
Action On November 3, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to do the following: Interim Recommendations until your EKOS CU4.0 console has been exchanged: In order to avoid the channel errors described in this notice: 1- Store the Control Unit at room temperature, in a well-ventilated area. 2- The console should be plugged in and powered on for 30 minutes prior to making connections and starting therapy to allow the Control Unit to warm up to operating temperature (+15¿C to +40¿C) Customers were also asked to complete and return the verification form to their local Boston Scientific office. The recalling firm will provide affected accounts with an updated CU 4.0 unit with a newly designed RF board.
Quantity in Commerce 90 (OUS)
Distribution No US distribution. Foreign distribution to Latin America and EU.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = BTG International, Inc.
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