Z-0133-2014Class II

The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per...

Name: Z-0133-2014 The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per...
Creator: EKOS Corporation
Published: 2013-10-02
License: https://open.fda.gov/license/

EKOS Corporation / initiated 2013-10-02 / Terminated

FDA source

EKOS Corporation began a recall of The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery... on 2013-10-02. FDA classified it as Class II and gives the reason as "The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0133-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-02
Posted: 2013-11-01
Terminated: 2013-11-22
Recalling firm: EKOS Corporation
Product: The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. 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 Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
FDA root cause: Mixed-up of materials/components
Action: EKOS notified their customer by email on October 2, 2013, about the recall. EKOS has requested the customer to return of EkoSonic Control Unit PT3B-783, so that it can be replaced. CORRECTIVE ACTION: This single affected unit will be reworked with the correct power entry module and released into finished goods as a refurbished control unit. EKOS did not distributed any affected devices in the US. For any questions, please call EKOS Corporation at 425-415-3100.
Quantity in commerce: one unit
Distribution: Worldwide Distribution in Germany only.
Product codes and lots: PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0133-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0133-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01

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)