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U.S. Department of Health and Human Services

Class 2 Device Recall EKOS Lysus Infusion System

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 Class 2 Device Recall EKOS Lysus Infusion Systemsee related information
Date Initiated by FirmSeptember 21, 2004
Date PostedNovember 01, 2005
Recall Status1 Terminated 3 on November 08, 2005
Recall NumberZ-0110-06
Recall Event ID 33394
510(K)NumberK042456 
Product Classification Catheter, Continuous Flush - Product Code KRA
ProductThe 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 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.
Code Information Serial numbers: 10098-012, 10098-011, 10098-055 Part number: 3929-001 Catalog number: 700-10301
Recalling Firm/
Manufacturer		 Ekos Corp
22030 - 20th Ave SE, Ste 101
Bothell WA 98021
For Additional Information ContactJocelyn Kersten
425-482-1108
Manufacturer Reason
for Recall		The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable.
FDA Determined
Cause 2		Other
ActionOn 9/21/04 the firm began visiting customers and replacing the catheter interface cables.
Quantity in Commerce3
DistributionUnits were shipped to hospitals, one each in WA, AZ, and OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KRA
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