ev3 Inc
Summary
- Total Recalls
- 11 (4 Class I)
- 510(k) Clearances
- 35
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0904-2025 | Class II | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X | December 10, 2024 |
| Z-0695-2022 | Class I | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For | February 4, 2022 |
| Z-0694-2022 | Class I | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For | February 4, 2022 |
| Z-0450-2022 | Class I | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, | December 6, 2021 |
| Z-0451-2022 | Class I | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6 | December 6, 2021 |
| Z-3055-2020 | Class II | Pacific Xtreme (PTCA Balloon Dilation Catheter) | August 26, 2020 |
| Z-2048-2016 | Class II | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB | May 23, 2016 |
| Z-1552-2016 | Class II | ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only. | March 29, 2016 |
| Z-0878-2015 | Class II | ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated fo | December 4, 2014 |
| Z-0879-2015 | Class II | ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated fo | December 4, 2014 |
| Z-1489-2014 | Class II | ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and e | April 9, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K141118 | NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER | July 18, 2014 |
| K132777 | NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER | September 26, 2013 |
| K130911 | RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER | May 24, 2013 |
| K123544 | RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER | February 12, 2013 |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE | October 27, 2011 |
| K111723 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | October 27, 2011 |
| K111490 | MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND D | September 16, 2011 |
| K110319 | EVERCROSS 0.035 OTW PTA DILATATION CATHETER | April 14, 2011 |
| K103618 | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM | January 5, 2011 |
| K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER | December 6, 2010 |
| K100063 | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BA | February 2, 2010 |
| K093750 | ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED | December 9, 2009 |
| K093286 | POWERCROSS .018 OTW PTA DILATION CATHETER | November 13, 2009 |
| K093301 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | November 6, 2009 |
| K092299 | TRAILBLAZER SUPPORT CATHETER | August 7, 2009 |
| K090849 | MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 | May 1, 2009 |
| K090728 | HYPERGLIDE OCCLUSION BALLOON SYSTEM | April 16, 2009 |
| K082854 | NANOCORSS .014 OTW PTA DILATATION CATHETER | December 4, 2008 |
| K082579 | EVERCROSS .035 OTW PTA DILATATION CATHETER | November 20, 2008 |
| K072301 | 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 | March 18, 2008 |