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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number 150910004. Expiration date is August 15, 2018. Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- EKOS Corporation
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot Number 150910004. Expiration date is August 15, 2018. Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
Distribution:
Distributed in: AZ, CA, MA, MI, OH, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0864-2016
Related Recalls
Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.