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U.S. Department of Health and Human Services

Class 2 Device Recall EKOS

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  Class 2 Device Recall EKOS see related information
Date Initiated by Firm October 13, 2022
Date Posted October 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-0149-2023
Recall Event ID 90984
510(K)Number K162771  K183361  K200648  
Product Classification Mechanical thrombolysis catheter - Product Code QEY
Product EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Code Information Serial numbers CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804, CU4.0-01835, CU4.0-01840, CU4.0-01843, CU4.0-01897, CU4.0-01980, CU4.0-02022, CU4.0-02146, and CU4.0-02026, UPN 600-40500, GTIN 00858593006462.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Rebecca KinKead Rubio
763-494-1133
Manufacturer Reason
for Recall		 Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued customer letters dated 10/13/2022 via FedEx overnight delivery on 10/13/2022 informing the customer certain serial numbers of the control units were shipped without an instruction for use (IFU) or contained an incorrect IFU. The customer was requested to complete and return the acknowledgment form to indicate receipt of the letter and the EKOS Control Unit 4.0 Instructions for Use (IFU). If the customer is a distributor, they are to follow the attached instructions (complete and return the acknowledgment form and place the provided IFU with their EKOS Control Unit 4.0 Console) and forward the notification to their customers. If the customer is a facility that has sent products to another hospital within their network, they are to follow the same attached instructions and ensure the notification is forwarded to the other hospitals if necessary.
Quantity in Commerce 16 consoles
Distribution Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong.
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 = QEY and Original Applicant = BTG International, Inc.
510(K)s with Product Code = QEY and Original Applicant = EKOS Corporation
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