Elana Catheter Sizer 2 — Class II medical device recall Z-1143-2013
Terminated recall by Elana, Inc., reported 2013-04-24, distributed in NY, PA, TX. Distribution of an unapproved device into interstate commerce.
| Recall number | Z-1143-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elana, Inc., Columbia, MD, United States |
| Recall initiated | 2013-02-14 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-05-09 |
| Distributed | NY, PA, TX |
| Quantity | 3 devices |
| Reason classes | unapproved product |
| Model numbers | 280, 706, 758, 776 |
Product
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Reason for recall
Distribution of an unapproved device into interstate commerce.
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-1143-2013. 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.