Z-2148-2015Class II

The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the...

Name: Z-2148-2015 The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the...
Creator: EKOS Corporation
Published: 2015-06-24
License: https://open.fda.gov/license/

EKOS Corporation / initiated 2015-06-24 / Terminated / root cause: supplier

FDA source

EKOS Corporation began a recall of The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic... on 2015-06-24. FDA classified it as Class II and gives the reason as "The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2148-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-07-20
Terminated: 2015-08-25
Recalling firm: EKOS Corporation
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.
Product code: KRA Catheter, Continuous Flush
Reason for recall: The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer. The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment. Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter. Customers with questions can contact EKOS Customer Service at 1-888-400-3567.
Quantity in commerce: 46 units
Distribution: Nationwide Distribution
Product codes and lots: CIC Serial Numbers: 19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103, 19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112, 19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118, 19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127, 19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135, 19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144, 19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153, 19598-154, 19598-156, 19598-157, 19598-158.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2148-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2148-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

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)