FDA Device recall Z-2854-2016
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter by Ekos, citing 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-….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2854-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-09 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ekos |
| Distribution | n/a |
Product
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Reason
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.
Identifiers
| code_info | Table 1: Device Identification Information Catalog Number; Lot Number; Serial Number; Expiration Date 500-5518;…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 (in |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2854-2016%22
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