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 consists of three main components, a single use Lysus Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus Infusion Catheter System.
FDA Recall Z-0111-06 · Posted 2005-11-01
Recalling FirmEkos Corp
Recall StatusTerminated
Product CodeKRA
Date Initiated2004-11-22
Date Terminated2005-11-09
Product Quantity134 kits
Reason for Recall
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
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.