Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 250 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. The hazard involves particulates (fibers) in a medical device, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Genzyme Corporation, a Sanofi company, is recalling 250 units of LeGoo Endovascular Occlusion Gel-2.5 mL (Product Number: PV-250). The recall is due to the presence of particulates, specifically fibers, within the product. LeGoo is a water-soluble, biocompatible polymer used for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
The affected product was 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 product and contact Genzyme Corporation for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 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. Le
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- Hazard
- Affected units
- 250
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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