Boston Scientific recalls EKOS Control System CU 4.0 units with older RF board design that may fail at low temperatures. Affected units have specific serial numbers listed in the recall notice.
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.
Boston Scientific is recalling EKOS Control System CU 4.0 devices that contain an older RF board design which could fail at lower temperatures. This recall is a follow-up to a previous safety notice and involves replacing the RF board with a redesigned version to prevent potential internal failures.
The older RF board design in some EKOS CU 4.0 consoles could fail at lower temperatures, potentially causing internal board failures. This recall addresses a redesign to prevent such failures without immediate safety risks.
Medical professionals using the EKOS Control System CU 4.0 for endovascular treatments are affected. The risk is low as the issue involves potential internal board failures at lower temperatures, not immediate safety hazards.
Check if your EKOS Control System CU 4.0 console has serial numbers listed in the recall notice (e.g., CU4.0-01062 through CU4.0-01299). The device is used for endovascular treatments and includes a reusable control unit.
Identify if your console has a serial number from the list provided in the recall notice (e.g., CU4.0-01062 through CU4.0-01299).
This recall is a follow-up to a previous safety notice. The older RF board design in some EKOS CU 4.0 consoles could fail at lower temperatures, so Boston Scientific redesigned the board to prevent potential internal failures.
Boston Scientific will replace the RF board with the newly designed version for affected units. You do not need to stop using the device immediately as the risk is low.
Yes, affected units have specific serial numbers listed in the recall notice (e.g., CU4.0-01062 through CU4.0-01299).
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0637-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0637-2021 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
