EkoSonic Endovascular System — Class II medical device recall Z-0864-2016
Terminated recall by EKOS Corporation, reported 2016-03-02, distributed in AZ, CA, MA, MI, OH, VA. The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Cat
| Recall number | Z-0864-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EKOS Corporation, Bothell, WA, United States |
| Recall initiated | 2016-01-21 |
| Classified | 2016-02-24 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-03-15 |
| Distributed | AZ, CA, MA, MI, OH, VA |
| Quantity | 10 units |
| Reason classes | labeling |
| Lot numbers | 150910004 |
| Serial numbers | 001, 002, 003, 004, 005, 006, 007, 008, 009, 010 |
| Model numbers | 500-56112 |
| Expiration dates | 2018-08-15 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0864-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.