Ekos Corp The Lysus Infusion System - Catheter Interface Cable. 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 D Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Lysus Infusion System - Catheter Interface Cable. 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 D
Brand
Ekos Corp
Lot Codes / Batch Numbers
Serial numbers: 10098-012, 10098-011, 10098-055 Part number: 3929-001 Catalog number: 700-10301
Products Sold
Serial numbers: 10098-012, 10098-011, 10098-055 Part number: 3929-001 Catalog number: 700-10301
Ekos Corp is recalling The Lysus Infusion System - Catheter Interface Cable. The Lysus Infusion System employs high freque due to The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable.
Recommended Action
Per FDA guidance
On 9/21/04 the firm began visiting customers and replacing the catheter interface cables.
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, IN, OH, WA
Page updated: Jan 10, 2026