Occluder, Internal Vessel, Temporary
FDA product code OBC · Class III (high risk) · Cardiovascular
For temporarily occluding vessels during anastomosis procedures.
0510(k) clearances
1PMA approvals
18recalls
PMA approvals
- P110003 Legoo · Genzyme Corp. · 09/28/2011
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2156-2013 Class II | LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2155-2013 Class II | LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2154-2013 Class II | LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2153-2013 Class II | LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2152-2013 Class II | LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2151-2013 Class II | LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2150-2013 Class II | LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2149-2013 Class II | LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2148-2013 Class II | LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2147-2013 Class II | LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2146-2013 Class II | LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number:…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2145-2013 Class II | LeGoo Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2144-2013 Class II | LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2143-2013 Class II | LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2142-2013 Class II | LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2141-2013 Class II | LeGoo Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number:…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2140-2013 Class II | LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |
| Z-2139-2013 Class II | LeGoo Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number:…Product contains particulates (fibers) | Genzyme Corporation, A Sanofi Company | 06/21/2013Terminated |