Micro Therapeutics Inc, Dba Ev3 Neurovascular
FDA Regulatory Profile
Summary
- Total Recalls
- 14 (9 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1528-2020 | Class I | ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascul | February 14, 2020 |
| Z-1527-2020 | Class I | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. | February 14, 2020 |
| Z-3022-2018 | Class II | ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIU | August 10, 2018 |
| Z-1701-2018 | Class I | MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 | February 26, 2018 |
| Z-0310-2017 | Class I | X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-3 | October 5, 2016 |
| Z-0309-2017 | Class I | Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: Th | October 5, 2016 |
| Z-0308-2017 | Class I | Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature fo | October 5, 2016 |
| Z-0307-2017 | Class I | Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatm | October 5, 2016 |
| Z-0120-2016 | Class II | -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex | September 4, 2015 |
| Z-1453-2014 | Class I | Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurys | April 1, 2014 |
| Z-1454-2014 | Class I | Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body remo | April 1, 2014 |
| Z-2045-2013 | Class II | Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovasc | July 19, 2013 |
| Z-2471-2012 | Class II | UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC F | September 23, 2011 |
| Z-2472-2012 | Class II | Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed | September 23, 2011 |