Reported Jul 29, 2015 · Terminated
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic…
EKOS Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: EKOS Corporation · 11911 N Creek Pkwy S · Bothell, WA · 98011-8809
Is this the product you have?
- The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System
- consists of three main components-a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device
- Lot codes and dates
- CIC Serial Numbers
19598-09519598-09719598-09919598-10019598-10219598-10319598-10619598-10719598-10819598-11019598-11119598-11219598-11319598-11419598-11519598-11619598-11719598-11819598-11919598-12019598-12219598-12519598-12619598-12719598-12819598-13019598-13119598-13219598-13319598-13519598-13619598-13919598-14019598-14119598-14319598-14419598-14519598-14619598-14719598-15119598-15219598-15319598-15419598-15619598-15719598-158
- CIC Serial Numbers
- Amount recalled
- 46 units
Where it was sold
- Nationwide
Why it was recalled
The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
This product could cause temporary or reversible health problems — stop using it.
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