Genzyme Corporation, A Sanofi Company Recall: LeGoo Internal Vessel Occluder .25mL Product
Genzyme Corporation, A Sanofi Company Recall: LeGoo Internal Vessel Occluder .25mL Product is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Genzyme Corporation, A Sanofi Company; Product: LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatibl
| Recalling firm | Genzyme Corporation, A Sanofi Company |
|---|---|
| Product | LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. |
| Reason for recall | Product contains particulates (fibers) |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK. |
| Recall initiated | 20130621 |
| Recall number | Z-2148-2013 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
Try RecallGuard →