Device product
LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT 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.
Z-2154-2013
Product summary
- Event
- Event 65485
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 units
- Official record key
device-enforcement:Z-2154-2013
Official wording
Reason: Product contains particulates (fibers)
Code information: All lot codes
Distribution pattern: 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.
Derived failure modes
-
Foreign material or chemical contamination
particulates