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 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.

Recall number

Z-0111-06

Recalling firm

Ekos Corp

Product

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.

Status

Terminated

Initiated

2004-11-22

Posted

2005-11-01

Terminated

2005-11-09

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.

Lot, serial or model codes

Serial #s 040914006-004, 040914006-008, 040914007-006, 040914008-003, 040928003-002, 040928003-005, 040928003-009, 040928004-002, 040928005-004, 040928006-002, 040928006-003, 040928006-006, 041013005-004, 040702005-007, 040702005-008, 040719001-005, 040719001-006, 040913002-001, 040913002-002, 040913002-003, 040914007-002, 040914010-001, 040928004-005, 041013006-014, 040928003-012, 040928003-013, 041013005-006, 041013005-007, 041013006-011, 041013006-017, 040719002-003, 040322001-003, 040322001-006, 040322001-013, 040420001-001, 040420001-002, 040420001-004, 040420001-005, 040420001-006, 040420001-007, 040420001-008, 040420001-009, 040420001-010, 040420001-011, 040702005-001, 040702005-002, 040702006-001, 040702006-002, 040928004-004, 040928005-002, 040928005-005, 040928006-004, 040928006-005, 040702005-003, 040702005-004, 040702006-003, 040702006-004, 040719001-001, 040719001-002, 040719002-002, 040719003-001, 040719003-002, 040914007-005, 040914008-002, 040914009-003, 040928004-001, 040928006-009, 040928006-010, 040928007-002, 040702005-005, 040702005-006, 040702006-005, 040719001-003, 040719001-004, 040909003-001, 040909003-002, 040913002-004, 040913002-005, 040914006-007, 040914007-003, 040914007-004, 040914009-004, 040928003-001, 040928004-008, 040928005-006, 040928006-001, 040928007-001, 041013005-005, 041013006-012, 041013006-013, 041119002-001, 041119003-001, 040719001-007, 040914006-003, 040914007-001, 040914008-001, 040914009-001, 040928003-010, 040928004-006, 040928004-007, 041013004-001, 041013004-002, 041013004-003, 041013006-008, 041013006-015, 040420001-003, 040719001-008, 040719002-001, 040914006-001, 040914006-005, 040914006-006, 040914006-009, 040914006-010, 040914008-004, 040928003-003, 040928003-004, 040928003-011, 040928003-014, 040928004-003, 040928005-007, 040928005-008, 041013006-009, 041013006-016, 041013006-018, 050204002-001, 050204002-002, 050204002-003, 050204002-004, 050204002-005, 050209002-001, 050209002-002, 050209002-003, 050209002-004, 050209002-005   Catalog # & Part #: 500-52112, 3383-002; 500-52124, 3393-004; 500-52124, 3393-006; 500-52150, 3393-007

510(k) numbers

["K042456"]

PMA numbers

not on file

Product code

KRA

Firm FEI

3001627457

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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