Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates
Genzyme is recalling LeGoo Internal Vessel Occluder 5mL units because they contain fiber particulates. The recall covers 308 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 the presence of particulates in a medical device intended for injection into blood vessels represents a risk of harm where injury has not yet been reported.
Plain-English summary
Genzyme Corporation, a Sanofi company, is recalling 308 units of LeGoo Internal Vessel Occluder 5mL (Product Number: 10-0500). 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. All lot codes are included in this recall.
Healthcare providers and patients should stop using the affected LeGoo Internal Vessel Occluder units and contact Genzyme Corporation for further instructions on returns or replacements.
The recalled product
- Product
- LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 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 tempo
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- Affected units
- 308
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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