Recall Z-2148-2015— EKOS Corporation
Class II · Terminated
Class II FDA medical device recall by EKOS Corporation, initiated 2015-06-24, terminated 2015-08-25. It names 3 FDA 510(k) clearances: K140151, K111705, K081467. 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.. Reason: The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit..
- Recalling firm
- EKOS Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-24
- Terminated
- 2015-08-25
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
3 on FDA's record- K140151 — EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
- K111705 — EKOSONIC ENDOVASCULAR SYSTEM
- K081467 — EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.