USE — Class II medical device recall Z-1362-2016
Terminated recall by Us Endovascular, reported 2016-04-20, distributed in AR, CA, FL, LA, MI, MO, MS, NY…. Product may kink during use rendering the product unusable.
| Recall number | Z-1362-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Us Endovascular, Saint Louis, MO, United States |
| Recall initiated | 2016-02-11 |
| Classified | 2016-04-11 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2017-11-30 |
| Distributed | AR, CA, FL, LA, MI, MO, MS, NY, TN, TX |
| Quantity | 843 catheters |
| Lot numbers | 1717082810164720, 1717082810164730, 1717082810164740, 1717082810164750, 1717082810164760, 1717082810164770, 1717082810164780, 1717082810164790, 1717082810164800, 1717082810164810, 1717082810164820, 1717082810164830, 1717082810164850, 1717082810164860, 1717082810164870, 1717082810164890, 1717082810164900, 1717082810164910, 1717101610166230, 1717101610166240, 1717101610166250, 1717101610166260, 1717101610166270, 1717101610166280, 1717101610166290, 1717101610166300, 1717101610166310, 1717101610166320, 1717101610166330, 1717101610166340, 1717101610166350, 1717101610166360, 1717101610167680, 1717101610169170, 1717101610169180, 1717101610169190, 1718010810171540, 1718010810171550, 1718010810171560, 1718010810171570 and 16 more |
Product
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Reason for recall
Product may kink during use rendering the product unusable.
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-1362-2016. 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.