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 Recall
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According to the U.S. Food and Drug Administration (FDA)
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
Brand
Ekos Corp
Lot Codes / Batch Numbers
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
Products Sold
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
Ekos Corp is recalling Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high freq due to During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, IL, IN, OH, WA
Page updated: Jan 10, 2026