Boston Scientific recalls EKOS Control Unit 4.0 consoles with missing or incorrect instructions. Affected units have specific serial numbers and GTIN. Consumers should contact the company for details.
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Boston Scientific is recalling EKOS Control Unit 4.0 consoles that were shipped without or with incorrect instructions. This could lead to improper use of the EkoSonic Endovascular System, potentially causing safety issues.
Consoles shipped without or with incorrect instructions could lead to improper use of the EkoSonic Endovascular System. This might cause safety issues during medical procedures, but the hazard is not described as causing serious injury in normal use.
Users of the EkoSonic Endovascular System who own the recalled EKOS Control Unit 4.0 consoles with specific serial numbers or GTIN. Medical professionals using the system are most at risk.
Check for serial numbers CU4.0-01438 through CU4.0-02026 or GTIN 00858593006462 on the console. The product is part of the EkoSonic Endovascular System.
Reach out to Boston Scientific for specific guidance on the recalled units and next steps.
It is a component of the EKOS Control System 4.0, which is part of the EkoSonic Endovascular System.
Consoles with serial numbers CU4.0-01438 through CU4.0-02026 or GTIN 00858593006462.
The consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0149-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0149-2023 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.
