EKOS Control System — Class II medical device recall Z-0637-2021
Ongoing recall by Boston Scientific Corporation, reported 2020-12-23. This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has b
| Recall number | Z-0637-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2020-11-03 |
| Classified | 2020-12-17 |
| Reported by FDA | 2020-12-23 |
| Quantity | 90 |
| Serial numbers | CU4.0-01062, CU4.0-01063, CU4.0-01066, CU4.0-01068, CU4.0-01069, CU4.0-01070, CU4.0-01072, CU4.0-01073, CU4.0-01074, CU4.0-01076, CU4.0-01078, CU4.0-01079, CU4.0-01081, CU4.0-01083, CU4.0-01084, CU4.0-01086, CU4.0-01088, CU4.0-01089, CU4.0-01090, CU4.0-01091, CU4.0-01093, CU4.0-01094, CU4.0-01095, CU4.0-01096, CU4.0-01097 and 81 more |
Product
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0637-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.