Ev3, Inc.
Ev3, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2014, with 11 FDA device recalls on record.
Top product codes for Ev3, Inc.
FDA recalls by Ev3, Inc.
10 most recent of 11- Z-0904-2025 — Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 150CM; 10) AB14W050150150, Size: 5MM X 150MM X 150CM; 11) AB14W050200090, Size: 5MM X 200MM X 90CM; 12) AB14W050200150, Size: 5MM X 200MM X 150CM; 13) AB14W060040090, Size: 6MM X 40MM X 90CM; 14) AB14W060040150, Size: 6MM X 40MM X 150CM; 15) AB14W060060150, Size: 6MM X 60MM X 150CM; 16) AB14W060080150, Size: 6MM X 80MM X 150CM; 17) AB14W060100150, Size: 6MM X 100MM X 150CM; 18) AB14W060120150, Size: 6MM X 120MM X 150CM; 19) AB14W060150150, Size: 6MM X 150MM X 150CM; 20) AB14W060200150, Size: 6MM X 200MM X 150CM; Balloon Dilatation Catheter
- Z-0694-2022 — Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
- Z-0695-2022 — Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
- Z-0450-2022 — Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.
- Z-0451-2022 — Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.
- Z-3055-2020 — Pacific Xtreme (PTCA Balloon Dilation Catheter)
- Z-2048-2016 — EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
- Z-1552-2016 — ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
- Z-0878-2015 — ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
- Z-0879-2015 — ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ev3, Inc.
- K141118 — NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
- K132777 — NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
- K130911 — RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
- K123544 — RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
- K111010 — SPIDERFX EMBOLIC PROTECTION DEVICE
- K111723 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- K111490 — MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
- K110319 — EVERCROSS 0.035 OTW PTA DILATATION CATHETER
- K103618 — TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
- K103322 — EVERCROSS 0.035 OTW PTA DILATION CATHETER
- K100063 — HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
- K093750 — ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
- K093286 — POWERCROSS .018 OTW PTA DILATION CATHETER
- K093301 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- K092299 — TRAILBLAZER SUPPORT CATHETER
- K090849 — MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
- K090728 — HYPERGLIDE OCCLUSION BALLOON SYSTEM
- K082854 — NANOCORSS .014 OTW PTA DILATATION CATHETER
- K082579 — EVERCROSS .035 OTW PTA DILATATION CATHETER
- K072301 — 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
- K063785 — SPIDERFX EMBOLIC PROTECTION DEVICE
- K063204 — SPIDERFX EMBOLIC PROTECTION DEVICE
- K061566 — PRIMUS GPS BILIARY STENT SYSTEM
- K062201 — SPIDERX EMBOLIC PROTECTION DEVICE
- K053195 — SPIDERX EMBOLIC PROTECTION DEVICE
- K060057 — PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
- K052659 — SPIDERX EMBOLIC PROTECTION DEVICE
- K043243 — PRIMUS STENT AND DELIVERY SYSTEM
- K042204 — MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
- K040653 — PARAMOUNT MINI GPS BILIARY STENT SYSTEM
- K040345 — MODIFICATION TO NITREX NITINOL GUIDEWIRE
- K033314 — PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
- K033134 — MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
- K032580 — PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
- K032206 — PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.