EKOS + recallZ-0149-2023 · Boston Scientific Corporation · initiated Oct 13, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0149-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 13, 2022
- Posted by the FDA
- Oct 28, 2022
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 16 consoles
- Product code
- QEY
- FDA submissions
- K162771, K183361, K200648
- 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.
Product description
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 (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EKOS™ EKOS Control Unit 4.0Boston Scientific Corporation · Catheter, Continuous Flush1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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