Recall Z-0111-06 ยท KRA Catheter, Continuous Flush
Ekos Corp
Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus Infusion System c
| Date | Nov 1, 2005 (initiated Nov 22, 2004) |
| Status | Terminated |
| Reason | During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when transiting tight bend radii; specifically the aortic bifurcation. In one case, the USC fractured within the DDC when the user attempted to withdraw the USC after resistance was encountered |
| Root cause | Other |
| Action | On 11/22/04 the firm issued letters to those customers that had product. The letters advised of the problem and provided amended use instructions.The firm continued to ship product and on 3/10/05 the firm visited consignees, replacing the catheters. |
| Quantity | 134 kits |
| Distribution | Kits were distributed to 6 hospitals in the US, 1 each located in AZ, OH, WA, FL, IL, and CA. The firm also distributed to a customer in Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042456 | Lysus Infusion System Ekos Corp., Sep 23, 2004 |