FDA Device recall Z-1362-2016
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter by Us Endovascular, citing product may kink during use rendering the product unusable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1362-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-11 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Us Endovascular |
| Distribution | AR, CA, FL, LA, MI, MO, MS, NY, TN, TX |
Product
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Reason
Product may kink during use rendering the product unusable.
Identifiers
| code_info | All references USE .014RX. Lot numbers: 1717082810164720 1717082810164720 1717082810164720 1717082810164720 1…All references USE .014RX. Lot numbers: 1717082810164720 1717082810164720 1717082810164720 1717082810164720 1717082810164720 1717082810164730 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166230 1717101610166250 1717101610166250 1717082810164740 1717101610166250 1717101610166250 1717082810164740 1717101610166250 1717101610166250 1717082810164760 1717101610166240 1717082810164760 1717082810164770 1717082810164770 1717101610166260 1717101610169180 1717101610169180 1717101610169180 1717101610166260 1717101610169180 1717101610166260 1717082810164770 1717101610166260 1718041510177220 1717082810164770 1717101610169180 1717082810164780 1717101610166270 1717082810164780 1717101610166270 1717101610166270 1717101610169190 1717082810164800 1717101610169190 171710161016 |
|---|
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-1362-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.