Recall Z-0637-2021 ยท KRA Catheter, Continuous Flush
Boston Scientific Corporation
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.
| Date | Nov 3, 2020 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | On November 3, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to do the following: Interim Recommendations until your EKOS CU4.0 console has been exchanged: In order to avoid the channel errors described in this notice: 1- Store the Control Unit at room temperature, in a well-ventilated area. 2- The console should be plugged in and powered on for 30 minutes prior to making connections and starting therapy to allow the Control Unit to warm up to operating temperature (+15C to +40C) Customers were also asked to complete and return |
| Quantity | 90 (OUS) |
| Distribution | No US distribution. Foreign distribution to Latin America and EU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 Btg International, Inc., Apr 5, 2019 |