BEUDAMED
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    Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries.

    FDA Recall
    Terminated ·Product code FGE·November 6, 2009

    SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, Irvine, CA 92618., Intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary or carotid vasculature.

    FDA Recall
    Terminated ·Product code MCW·January 21, 2010

    ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.

    FDA Recall
    Terminated ·Product code FGE·October 30, 2010

    Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, dba ev3 Neurovascular·Product code KRD·March 1, 2010

    Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, dba ev3 Neurovascular·Product code HCG·March 1, 2010

    ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. Intended as a palliative treatment of malignant neoplasms in the biliary tree.

    FDA Recall
    Terminated ·Product code FGE·March 31, 2010

    ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

    FDA Recall
    Terminated ·ev3, Inc.·Product code LIT·March 29, 2016

    ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,

    FDA Recall
    Terminated ·Product code FGE·July 1, 2008

    TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-035-150. Intended to guide and support a guide wire during access of the vasculature.

    FDA Recall
    Terminated ·Product code DQY·November 6, 2009

    Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011

    ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135 ,PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080. The Endovascular Company , 4800 Nathan Lane North, Plymouth, MN

    FDA Recall
    Terminated ·Product code FGE·July 1, 2008

    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011

    ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System, Rx Only, and SERB65-08-40-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.

    FDA Recall
    Terminated ·Product code FGE·June 10, 2009

    ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, Rx Only, and SERB65-06-80-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.

    FDA Recall
    Terminated ·Product code FGE·June 10, 2009

    ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-06-80-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.

    FDA Recall
    Terminated ·Product code FGE·June 10, 2009

    ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-08-40-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.

    FDA Recall
    Terminated ·Product code FGE·June 10, 2009

    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter

    FDA Enforcement
    Class II ·Terminated·Ev3, Inc.·April 30, 2014

    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

    FDA Enforcement
    Class II ·Terminated·Ev3, Inc.·June 29, 2016

    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.

    FDA Enforcement
    Class II ·Terminated·Ev3, Inc.·January 7, 2015

    ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

    FDA Enforcement
    Class II ·Terminated·ev3, Inc.·May 4, 2016