Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit

• • Terminated Z-2854-2016 FDA Class II ·initiated 9 Aug 2016 ·on shared 510(k) K140151

  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.

• • Terminated Z-0864-2016 FDA Class II ·initiated 21 Jan 2016 ·on shared 510(k) K140151

  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.

• • Terminated Z-2148-2015 FDA Class II ·initiated 24 Jun 2015 ·on shared 510(k) K140151

  The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K140151 ↗

FDA Product Code

QEY

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• EKOS ultrasound EVD Device, EVD Control Unit

  Class II

  FDA 510(k) K172035 Active Cleared 24 Mar 2018

• EkoSonic Endovascular System with Control Unit 4.0 Open recall

  Class II

  FDA 510(k) K162771 Active Cleared 24 Feb 2017

• EkoSonic Endovascular Device

  Class II

  FDA 510(k) K191119 Active Cleared 23 Aug 2019

• EkoSonic Endovascular System

  Class II

  FDA 510(k) K182324 Active Cleared 26 Nov 2018

• EkoSonic Endovascular Device with Control Unit 4.0 Open recall

  Class II

  FDA 510(k) K183361 Active Cleared 5 Apr 2019