Recall Z-2148-2015
EKOS Corporation · initiated June 24, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: CIC Serial Numbers: 19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103, 19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112, 19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118, 19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127, 19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135, 19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144, 19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153, 19598-154, 19598-156, 19598-157, 19598-158.
Reason for recall
The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
FDA-determined cause: Vendor change control
Action taken
Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer. The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment. Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter. Customers with questions can contact EKOS Customer Service at 1-888-400-3567.
Details
- Recall number
- Z-2148-2015
- Initiated
- June 24, 2015
- Posted by FDA
- July 20, 2015
- Terminated
- August 25, 2015
- Product code
- KRA – Catheter, Continuous Flush
- Quantity
- 46 units
- Distribution
- Nationwide Distribution
- Recalling firm
- EKOS Corporation, Bothell, WA