Brand

Ev3 Inc. Recalls

10 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Ev3 Inc..

10Total Recalls
3Critical
109,180Units Affected
Dec 10, 2024Most Recent
All Recalls

Every Ev3 Inc. Recall

Sorted by most recent. Click any recall for full details.

10 recalls
High RiskFDA
Ev3 Inc
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Si...
Surgical Devices·5,189 affected·Dec 10, 2024
CriticalFDA
Ev3 Inc.
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Medical Devices·245 affected·Feb 4, 2022
CriticalFDA
Ev3 Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014...
Surgical Devices·71,260 affected·Dec 6, 2021
CriticalFDA
Ev3 Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014"...
Surgical Devices·28,094 affected·Dec 6, 2021
High RiskFDA
Ev3 Inc.
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Surgical Devices·4,286 affected·Aug 26, 2020
High RiskFDA
Ev3, Inc.
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex"...
Medical Implants·2 affected·May 23, 2016
High RiskFDA
Ev3, Inc.
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Surgical Devices·27 affected·Mar 29, 2016
High RiskFDA
Ev3, Inc.
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 r...
Medical Implants·24 affected·Dec 4, 2014
High RiskFDA
Ev3, Inc.
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high r...
Medical Implants·14 affected·Dec 4, 2014
High RiskFDA
Ev3, Inc.
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatatio...
Surgical Devices·39 affected·Apr 9, 2014