Lower risk Medical device recall · FDA · Published November 3, 2020

Boston Scientific EKOS Control System CU 4.0 Recall: RF Board Design Fix

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0637-2021Medical device Boston Scientific ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmBoston Scientific Corporation300 Boston Scientific Way · Marlborough, MA 01752-1291

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/63984-boston-scientific-ekos-control-system-cu-4-0-recall-rf.

Source Summary by GovInfoNow · govinfonow.com/recall/63984-boston-scientific-ekos-control-system-cu-4-0-recall-rf · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0637-2021

Cite this page

“Boston Scientific EKOS Control System CU 4.0 Recall: RF Board Design Fix.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63984-boston-scientific-ekos-control-system-cu-4-0-recall-rf. Based on FDA recall #Z-0637-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2021%22&limit=1).

The FDA announced on 2020-11-03 that Boston Scientific Corporation is recalling the EKOS Control System (CU) 4.0 due to potential internal board failures at lower temperatures. Owners should have affected consoles replaced with newly designed units.

How to tell if you have it

Brand: Boston Scientific
Product: EKOS Control System (CU) 4.0
UPN: 600-40500
Serial numbers: CU4.0-01062 through CU4.0-01299 (specifically listed in record)
Distribution: Foreign distribution to Latin America and EU; no US distribution

The hazard

The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since 2017-06-01. Recent brand recalls include the Imager II Angiographic Catheters Recall (2026-08-24) and the LUX-Dx Cardiac Monitor System Recall (2026-08-06). Other recent recalls of similar products include the CSK Electrodes Recall (2026-04-29), the Philips Allura Xper FD10C Medical System Recall (2025-12-15) and the Philips Allura Xper FD10F Medical System Recall (2025-12-15).

How to tell if you have this one

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.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Console Serial Number
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).

How this recall unfolded

Recall timeline

FDA published this recall 50 days after the firm started it.

Nov 3, 2020Firm started the recall
Dec 17, 2020FDA classified it Class II
Dec 23, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/63984-boston-scientific-ekos-control-system-cu-4-0-recall-rf">Boston Scientific EKOS Control System CU 4.0 Recall: RF Board Design Fix (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0637-2021 (November 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0637-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.