Boston Scientific Corporation Recall: EKOS Control System (CU) 4.0. UPN 600-40500 The EkoS
Boston Scientific Corporation Recall: EKOS Control System (CU) 4.0. UPN 600-40500 The EkoS is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a sin
| Recalling firm | Boston Scientific Corporation |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | No US distribution. Foreign distribution to Latin America and EU. |
| Recall initiated | 20201103 |
| Recall number | Z-0637-2021 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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