Ev3, Inc.
Medical device manufacturer in Plymouth, MN.
40510(k) clearances
0PMA approvals
41recalls
Device types
- FGE Stents, Drains And Dilators For The Biliary… 12
- LIT Catheter, Angioplasty, Peripheral… 7
- MCW Catheter, Peripheral, Atherectomy 4
- DQY Catheter, Percutaneous 4
- DQX Wire, Guide, Catheter 3
- NTE Temporary Carotid Catheter For Embolic… 3
- NFA Temporary Coronary Saphenous Vein Bypass… 3
- MJN Catheter, Intravascular Occluding, Temporary 2
- KRA Catheter, Continuous Flush 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K141118 | Nanocross Eite 0.014 Over-The-Wire Pta Balloon Dilatation CatheterLIT · Special | 07/18/2014SE |
| K132777 | Nanocross Elite .14 Over-The-Wire Pta, Balloon Dilation CatheterLIT · Traditional | 09/26/2013SE |
| K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterLIT · Traditional | 05/24/2013SE |
| K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterLIT · Traditional | 02/12/2013SE |
| K111723 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | 10/27/2011SE |
| K111010 | Spiderfx Embolic Protection DeviceNTE · Traditional | 10/27/2011SE |
| K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…KRA · Special | 09/16/2011SE |
| K110319 | Evercross 0.035 Otw Pta Dilatation CatheterLIT · Special | 04/14/2011SE |
| K103618 | Turbohawk Peropheral Plaque Excision SystemMCW · Traditional | 01/05/2011SE |
| K103322 | Evercross 0.035 Otw Pta Dilation CatheterLIT · Traditional | 12/06/2010SE |
| K100063 | Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide…MJN · Special | 02/02/2010SE |
| K093750 | Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…KRA · Special | 12/09/2009SE |
| K093286 | Powercross .018 Otw Pta Dilation CatheterLIT · Special | 11/13/2009SE |
| K093301 | Turbohawk Peripheral Plaque Excision SystemMCW · Traditional | 11/06/2009SE |
| K092299 | Trailblazer Support CatheterDQY · Traditional | 08/07/2009SE |
| K090849 | Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090…DQY · Special | 05/01/2009SE |
| K090728 | Hyperglide Occlusion Balloon SystemMJN · Special | 04/16/2009SE |
| K082854 | Nanocorss .014 Otw Pta Dilatation CatheterDQY · Traditional | 12/04/2008SE |
| K082579 | Evercross .035 Otw Pta Dilatation CatheterDQY · Traditional | 11/20/2008SE |
| K072301 | 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05FGE · Traditional | 03/18/2008SESU |
| K063785 | Spiderfx Embolic Protection DeviceNFA · Special | 01/19/2007SE |
| K063204 | Spiderfx Embolic Protection DeviceNTE · Special | 11/14/2006SE |
| K061566 | Primus GPS Biliary Stent SystemFGE · Special | 08/31/2006SESU |
| K062201 | Spiderx Embolic Protection DeviceNFA · Special | 08/11/2006SE |
| K053195 | Spiderx Embolic Protection DeviceNFA · Traditional | 06/23/2006SE |
| K060057 | Protege Everflex Self-Expanding Biliary Stent SystemFGE · Special | 03/08/2006SESU |
| K052659 | Spiderx Embolic Protection DeviceNTE · Traditional | 02/17/2006SE |
| K051379 | Protege RX GPS Self-Expanding Nitrinol StentFGE · Special | 06/17/2005SESU |
| K050725 | Protege GPS Self-Expanding Nitinol StentFGE · Special | 04/20/2005SE |
| K043243 | Primus Stent and Delivery SystemFGE · Special | 12/09/2004SESU |
| K021096 | X-Sizer Catheter SystemMCW · Traditional | 09/08/2004SE |
| K042204 | Modification to Protege GPS Self-Expanding Nitinol StentFGE · Special | 08/23/2004SESU |
| K040653 | Paramount Mini GPS Biliary Stent SystemFGE · Special | 04/28/2004SESU |
| K040345 | Modification to Nitrex Nitinol GuidewireDQX · Special | 03/02/2004SE |
| K033314 | Protege GPS Self-Expanding Nitinol Stent and Delivery SystemFGE · Special | 11/21/2003SESU |
| K033134 | Modification to Paramount Mini Stent and Delivery SystemFGE · Special | 11/17/2003SESU |
| K032580 | Protege GPS Self-Expanding Nitinol Stent and Delivery SystemFGE · Special | 10/22/2003SESU |
| K032206 | Paramount Mini Stent and Delivery System Biliary IndicationFGE · Special | 08/08/2003SE |
| K031864 | Nitrex Nitinol GuidewireDQX · Special | 06/24/2003SE |
| K024021 | Nitrex Nitinol GuidewireDQX · Special | 01/24/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0904-2025 Class II | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size:…There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate… | 12/10/2024Open, Classified |
| Z-0695-2022 Class I | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number…The device has similarities in design to another device that the firm recently issued a field correction on… | 02/04/2022Terminated |
| Z-0694-2022 Class I | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number…The device has similarities in design to another device that the firm recently issued a field correction on… | 02/04/2022Terminated |
| Z-0451-2022 Class I | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT…Reports have been received of tip damage during use of the devices which resulted in some instances of tip… | 12/06/2021Terminated |
| Z-0450-2022 Class I | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT.…Reports have been received of tip damage during use of the devices which resulted in some instances of tip… | 12/06/2021Terminated |
| Z-3055-2020 Class II | Pacific Xtreme (PTCA Balloon Dilation Catheter)Labeling discrepancy for the Rated Burst Pressure (RBP) value. | 08/26/2020Terminated |
| Z-2048-2016 Class II | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide…Medtronic is issuing a medical device recall to return product potentially associated with an outer box… | 05/23/2016Terminated |
| Z-1552-2016 Class II | ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO…Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over… | 03/29/2016Terminated |
| Z-0879-2015 Class II | ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only.…Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 &… | 12/04/2014Terminated |
| Z-0878-2015 Class II | ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only.…Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 &… | 12/04/2014Terminated |
| Z-1489-2014 Class II | ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF:…Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product… | 04/09/2014Terminated |
| Z-0789-2011 | ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF…ev3 has determined that specific lots of the NanoCross .014 OTW PTA Dilatation catheters may crack or break… | 11/12/2010Terminated |
| Z-0626-2011 | ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent…Mislabeled size: Specific Protg GPS lots have product labeling that does not match the actual stent sizes… | 10/30/2010Terminated |
| Z-1598-2010 | ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF:…ev3 is conducting a voluntary recall on three lots of the Protg EverFlex" Biliary Stent System. They… | 03/31/2010Terminated |
| Z-1162-2010 | SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550…ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk Cutter Drivers (Model Number FG… | 01/21/2010Terminated |
| Z-0497-2010 | TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920…Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of… | 11/06/2009Terminated |
| Z-0478-2010 | Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6…ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length… | 11/06/2009Terminated |
| Z-2025-2009 | ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent…ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System… | 06/10/2009Terminated |
| Z-2024-2009 | ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent…ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System… | 06/10/2009Terminated |
| Z-2023-2009 | ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent…ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System… | 06/10/2009Terminated |
| Z-2022-2009 | ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent…ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System… | 06/10/2009Terminated |
| Z-1548-2008 | ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model…ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate… | 07/01/2008Terminated |
| Z-1547-2008 | ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent…ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate… | 07/01/2008Terminated |
| Z-2170-2008 | Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use…A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length… | 04/22/2008Terminated |
| Z-2169-2008 | Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan…A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length… | 04/22/2008Terminated |
| Z-1816-2008 | ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF…An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent. | 04/09/2008Terminated |
| Z-1815-2008 | ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot…Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was… | 04/02/2008Terminated |
| Z-1131-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1130-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1129-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1128-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1127-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1126-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1125-2008 | ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, ev3…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1124-2008 | ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, ev3…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1123-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan Lane…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1122-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, ev3, 4600 Nathan Lane…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1121-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1120-2008 | ev3 IntraStent Biliary Stent, Model Number: S10-26, ev3, 4600 Nathan Lane North…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-0992-2007 | Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile…Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr. | 05/18/2007Terminated |
| Z-0389-2007 | ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and… | 12/06/2006Terminated |