—#196394

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.

FDA product code: QEY — Mechanical Thrombolysis Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K162771, K183361, K200648
Affected lot / code info: 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.

Why it was recalled

Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-10-13
Posted by FDA: 2022-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196394. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.