Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
Genzyme Corporation is recalling 37 units of LeGoo Internal Vessel Occluder 10mL 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 37 units of LeGoo Internal Vessel Occluder 10mL (Product Number: 10-1000). The recall was initiated because the product contains particulates, specifically fibers.
LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties. It is 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 USA 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.
The recall applies to 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 Internal Vessel Occluder 10mL Product Number: 10-1000 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 temp
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- Hazard
- Affected units
- 37
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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