Devices

Device Recall LeGoo Endovascular Occlusion Gel1.0 mL LeGoo with 3 Cannula Pouch

Model / Serial
All lot codes
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
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.
Product Description
LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch || Product Number: CS-100 || 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.
Manufacturer
Genzyme Corporation, A Sanofi Company
1 Event
- Recall of Device Recall LeGoo Endovascular Occlusion Gel1.0 mL LeGoo with 3 Cannula Pouch

Manufacturer

Genzyme Corporation, A Sanofi Company

Manufacturer Address
Genzyme Corporation, A Sanofi Company, 175F New Boston St, Woburn MA 01801-6203
Manufacturer Parent Company (2017)
Sanofi
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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