ev3 Inc.
10 recalls on record · Latest: Jan 22, 2025
FDA Devices Moderate Jan 22, 2025
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X …
FDA Devices Critical Mar 16, 2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
FDA Devices Critical Jan 26, 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) …
FDA Devices Critical Jan 26, 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) C…
FDA Devices Moderate Oct 7, 2020
Pacific Xtreme (PTCA Balloon Dilation Catheter)
FDA Devices Moderate Jun 29, 2016
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expand…
FDA Devices Moderate May 4, 2016
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
FDA Devices Moderate Jan 7, 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 adve…
FDA Devices Moderate Jan 7, 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 adve…
FDA Devices Moderate Apr 30, 2014