EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter — Class II medical device recall Z-2854-2016
Terminated recall by EKOS Corporation, reported 2016-09-28. The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These
| Recall number | Z-2854-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EKOS Corporation, Bothell, WA, United States |
| Recall initiated | 2016-08-09 |
| Classified | 2016-09-21 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2016-10-05 |
| Countries outside the US | DE, NZ, TW |
| Quantity | 10 units |
| Serial numbers | 002R, 160711017, 160711017-001, 160711017-002, 160711017-003, 160711017-004, 160711017-005, 160711017-006, 160711017-007, 160711017-008, 160711017-009, 160711042, 160711042-010, 3001627457, 500-5512, 500-5518 |
Product
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2854-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.