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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75046

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 09, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
EKOS Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter

Z-2854-2016
Recall number
Z-2854-2016
Initiated
August 09, 2016
Classification
Class II
Status
Terminated
Recalling firm
EKOS Corporation
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

Three international consignees - Germany, New Zealand and Taiwan