FDA-Device2020-12-23Class II
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 Ultras
Hazard
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.
Sold states
No US distribution. Foreign distribution to Latin America and EU.
Affected count
90 (OUS)
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0637-2021More Boston Scientific Corporation recalls
- FDA-Device2026-07-22Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
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