Z-2854-2016Class II

EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter

Name: Z-2854-2016 EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Creator: EKOS Corporation
Published: 2016-08-09
License: https://open.fda.gov/license/

EKOS Corporation / initiated 2016-08-09 / Terminated / root cause: packaging

FDA source

EKOS Corporation began a recall of EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter on 2016-08-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2854-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-09
Posted: 2016-09-21
Terminated: 2016-10-05
Recalling firm: EKOS Corporation
Product: EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Product code: KRA Catheter, Continuous Flush
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Storage
Action: All affected consignees were contacted by e-mail on August 9, 2016, and asked to sequester implicated devices.
Quantity in commerce: 10 units
Distribution: Three international consignees - Germany, New Zealand and Taiwan
Product codes and lots: Table 1: Device Identification Information Catalog Number; Lot Number; Serial Number; Expiration Date 500-5518; 160711017; 160711017-005; 06-30-2019 500-5518; 160711017; 160711017-006; 06-30-2019. 500-5518; 160711017; 160711017-003; 06-30-2019. 500-5518; 160711017; 160711017-004; 06-30-2019. 500-5512; 160711042; 160711042-010; 06-30-2019. 500-5518; 160711017; 160711017-001; 06-30-2019. 500-5518; 160711017; 160711017-002; 06-30-2019. 500-5518; 160711017; 160711017-007; 06-30-2019. 500-5518; 160711017; 160711017-008; 06-30-2019. 500-5518; 160711017; 160711017-009; 06-30-2019. 3001627457 08/09/2016-002R CONFIDENTIAL 3 ¿ Name, address, and type of responsible firm on label; number and description of private labels. Manufacturer: EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011 ¿ Collect a complete copy of all labeling (include product inserts, information sheets.) Applicable labeling is included in Attachment 1. B. CODE: ALL lot and/or serial numbers, batch numbers, catalog numbers, product numbers, packer or manufacturer numbers, etc., exactly as they appear on the product, container, or labeling. There are 10 total devices in distribution. Identification information for the implicated devices is found in Table 1: Table 1: Device Identification Information Catalog Number Lot Number Serial Number Expiration Date 500-5518 160711017 160711017-005 06-30-2019 500-5518 160711017 160711017-006 06-30-2019 500-5518 160711017 160711017-003 06-30-2019 500-5518 160711017 160711017-004 06-30-2019 500-5512 160711042 160711042-010 06-30-2019 500-5518 160711017 160711017-001 06-30-2019 500-5518 160711017 160711017-002 06-30-2019 500-5518 160711017 160711017-007 06-30-2019 500-5518 160711017 160711017-008 06-30-2019 500-5518 160711017 160711017-009 06-30-2019 ¿ Give a breakdown of the code Catalog Number consists of 7 digits (XXX-YYYY), where; ¿ XXX represents a product family, ¿ YYYY represents a specific configuration, such as working length/treatment zone length.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2854-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2854-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21

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)