FDA Medical Device Recalls (openFDA)
Us Endovascular: USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
- Recall number
- Z-1362-2016
- Recalling firm
- Us Endovascular
- Product
- USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
- Status
- Terminated
- Initiated
- 2016-02-11
- Posted
- not on file
- Terminated
- 2017-11-30
- Reason
- Product may kink during use rendering the product unusable.
- Root cause
- Device Design
- Action
- NATEC Medical ltd.sent an Urgent Medical Device Advisory Notice dated March 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Warnings: This device should be used only by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of angioplasty. What action do you need to take: 1. Always use a guiding catheter when contralateral access is needed. 2. Always insert cautiously the PTA catheter inside the guiding catheter, and if any resistance is felt, the cause should be determined via fluoroscopy. 3. For contralateral procedure, the USE014OTW has to be preferred to Ebony 014 Rx. NATEC Medical Ltd and our distributor US Endovascular are committed to keeping you and your healthcare professional informed of issues and solutions concerning our products and services. Should you have any questions regarding this or any other matter regarding your USE 014Rx PTA catheter, please do not hesitate to contact our distributor: US Endovascular at (314) 341-4930.
- Quantity
- 843 catheters
- Distribution
- US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.
- Lot, serial or model codes
- 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 1717101610169190 1717101610169190 1717101610166280 1717082810164810 1717082810164810 1717101610166290 1717082810164810 1717082810164810 1717101610166290 1717101610166290 1717101610166290 1717082810164810 1717082810164810 1717101610166290 1717101610166290 1717101610166290 1717101610166290 1717082810164810 1717101610166290 1717082810164810 1717082810164810 1717082810164810 1717082810164810 1717082810164820 1717082810164820 1717101610166300 1717082810164820 1717101610166300 1717101610166300 1717082810164820 1717101610166300 1717082810164820 1717101610166300 1717082810164820 1717082810164820 1717082810164820 1717101610166300 1717101610166310 1717101610166310 1717101610166310 1717082810164850 1717082810164850 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717101610166320 1717082810164850 1717082810164850 1717082810164860 1717101610166330 1717101610166330 1717101610166330 1717101610166330 1717101610166340 1717101610166340 1717101610166340 1717101610166340 1717101610166340 1717101610166340 1717082810164890 1717082810164890 1717082810164890 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717082810164890 1717101610166350 1717101610166350 1717082810164890 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717101610166350 1717082810164890 1717082810164890 1717082810164900 1717082810164900 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717101610166360 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1717082810164750 1718041510177210 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810171540 1718010810174410 1718010810174410 1718010810171540 1718051310179200 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1718010810171550 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1717082810164790 1718041510177230 1718051310179210 1718051310179210 1718051310179210 1718051310179210 1718041510177240 1718041510177240 1718041510177240 1718041510177240 1718041510177240 1718051310179220 1718041510177240 1718041510177240 1718041510177240 1718051310179220 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1717082810164830 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718010810171560 1718051310179230 1718051310179230 1718051310179230 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718010810171570 1718051310179240 1718051310179240 1718051310179240 1718051310179240 1718010810171570 1717082810164870 1717082810164870 1717082810164870 1717082810164870 1717101610169170 1717101610169170 1717101610169170 1717101610169170 1717082810164870 1717082810164870 1718071310185370 1718051310179250 1718051310179250 1718051310179250 1718051310179250 1718051310179250 1718051310179260 1718051310179260 1717082810164910 1717082810164910 1717082810164910 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717082810164910 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1717101610167680 1718061710181860 1718061710181860 1718061710181860 1718041510177250 1718041510177250 1718061710181900 1718061710181900 1718061710181900 1718061710181900 1718061710181900
- 510(k) numbers
- ["K152230"]
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 3010747597
- Firm city
- Saint Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28