Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are categorized as High severity.
Plain-English summary
Genzyme Corporation, a Sanofi company, is recalling 100 units of LeGoo Endovascular Occlusion Gel-1.0 mL with 3 Cannula Pouch (Product Number: CS-100). The recall was initiated because the product contains particulates, specifically fibers.
LeGoo is a water-soluble, biocompatible polymer indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. The affected units were distributed nationwide in the United States and internationally to various countries including Austria, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK.
The FDA has classified this recall as Class II, which means the use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote. Users should contact the manufacturer for further instructions regarding the affected product.
The recalled product
- Product
- 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 v
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- Hazard
- Affected units
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Genzyme Corporation, A Sanofi Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
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