Z-0864-2016Class II

EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use...

Name: Z-0864-2016 EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use...
Creator: EKOS Corporation
Published: 2016-01-21
License: https://open.fda.gov/license/

EKOS Corporation / initiated 2016-01-21 / Terminated / root cause: labeling and UDI

FDA source

EKOS Corporation began a recall of EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of... on 2016-01-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0864-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-21
Posted: 2016-02-24
Terminated: 2016-03-15
Recalling firm: EKOS Corporation
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.
Product code: KRA Catheter, Continuous Flush
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: All affected consignees were contacted by telephone January 20- 22, 2016. The URGENT VOLUNTARY PRODUCT RECALL letter, dated January 21, 2016, was sent to consignees. Consignees were advised that replacement devices were shipped to their facility on January 21, 2016 and should arrive there on January 22, 2016. Consignees with questions can call: Jocelyn Kersten Vice President, Regulatory and Clinical Affairs EKOS Corporation, a BTG International Group Company 425-415-3132 [email protected]
Quantity in commerce: 10 units
Distribution: Distributed in the states of AZ, CA, MA, MI, OH, and VA.
Product codes and lots: Lot Number 150910004. Expiration date is August 15, 2018. Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0864-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0864-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24

Product code KRA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)