Reported Mar 2, 2016 · Terminated
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use 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?
- EkoSonic Endovascular System, Catalog Number 500-56112. It 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, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
- Lot codes and dates
- Lot Number 150910004. Expiration date is August 15, 2018
- Serial numbers
001002003004005006007008009010
- Amount recalled
- 10 units
Where it was sold
Why it was recalled
The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.
This product could cause temporary or reversible health problems — stop using it.
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