Boston Scientific Recalls EKOS Control System Units Due to RF Board Failure
Boston Scientific is replacing 90 EKOS Control System 4.0 units in Latin America and the EU to prevent internal RF board failures at lower temperatures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a functional defect (board failure) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 90 EKOS Control System (CU) 4.0 units (UPN 600-40500) due to a defect in the Radio Frequency (RF) board. The recall is a follow-up to a Field Safety Notice dated April 30, 2019. The RF board has been redesigned to prevent occasional internal board failures that can occur at lower temperatures.
The affected devices are part of the EkoSonic MACH4 Endovascular (EKOS) System, which delivers physician-specified fluids and ultrasound to intravascular treatment sites. The recalled Control Units are reusable and connect to single-use infusion catheters and ultrasonic cores. The recall covers units with specific serial numbers listed in the agency documentation.
There is no US distribution for these units; they were distributed to Latin America and the European Union. Boston Scientific will replace all EKOS CU 4.0 consoles containing the old RF board design with newly designed units.
The recalled product
- 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…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 90
Distribution
Distribution scope not specified by the agency.
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