Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel 2.5 mL because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The presence of particulates in an injectable medical device presents a risk, but the source does not report specific injuries or deaths, fitting the Moderate criteria for a Class II recall without reported severe harm.
Plain-English summary
Genzyme Corporation, a Sanofi company, is recalling 100 units of LeGoo Endovascular Occlusion Gel 2.5 mL (Product Number: LG250IT). 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 Austria, Belgium, Canada, Denmark, Egypt, Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK.
The source text does not specify which lot codes are affected, though the structured metadata indicates "All lot codes." No specific dates of distribution or specific patient outcomes are provided in the source text.
The recalled product
- Product
- LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT 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
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- 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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