Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
Genzyme Corporation is recalling 331 units of LeGoo Internal Vessel Occluder 2.5mL because the product contains particulates (fibers). The recall covers 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 involves a medical device with a risk of harm (particulates/fibers) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Genzyme Corporation, A Sanofi Company, is recalling 331 units of LeGoo Internal Vessel Occluder 2.5mL (Product Number: 10-0250). 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, The Netherlands, 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 instructions on return or replacement.
The recalled product
- Product
- LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 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 tem
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- Hazard
- Affected units
- 331
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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