Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
Genzyme is recalling LeGoo Internal Vessel Occluder devices because they contain particulates (fibers). The recall affects 448 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 recall is classified as FDA Class II and involves a medical device with a risk of harm (particulates) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Genzyme Corporation, a Sanofi company, is recalling the LeGoo Internal Vessel Occluder .25mL (Product Number: 10-0025). The recall is being conducted 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 recall covers 448 units across all lot codes. These devices 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 U.S. Food and Drug Administration has classified this recall as Class II. Healthcare providers and patients should stop using the affected devices and contact Genzyme Corporation for further instructions.
The recalled product
- Product
- LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 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
- 448
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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