Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling 994 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 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. The hazard involves particulates (fibers) in a medical device, which is a quality defect without reported injuries or deaths in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Genzyme Corporation, A Sanofi Company, is recalling 994 units of LeGoo Endovascular Occlusion Gel, Product Number LG100. 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 recall includes all lot codes. Consumers and healthcare providers should stop using the affected product and contact Genzyme Corporation for further instructions.
The recalled product
- Product
- LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 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 ve
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- Affected units
- 994
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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- HighGenzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
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- HighGenzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
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