Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling 65 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers lots 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 65 units of LeGoo Endovascular Occlusion Gel-0.5 mL with 3 Cannula Pouch (Product Number: CS-50). 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 countries including Austria, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK.
The FDA has classified this as a Class II recall. Healthcare providers and patients should stop using the affected product and contact Genzyme Corporation for further instructions or a replacement.
The recalled product
- Product
- LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 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 ve
- Manufacturer
- Genzyme Corporation, A Sanofi Company
- Hazard
- Affected units
- 65
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
Same manufacturer · Genzyme Corporation, A Sanofi Company
See all →- HighGenzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
FDA (Devices) · 2013-09-11
- HighGenzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
FDA (Devices) · 2013-09-11
- HighGenzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates
FDA (Devices) · 2013-09-11
- HighGenzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
FDA (Devices) · 2013-09-11
- HighGenzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
FDA (Devices) · 2013-09-11
Same hazard · particulates
See all →- CriticalHalyard Convenience Kits Recalled Due to Particulates in Manifolds
FDA (Devices) · 2026-08-12
- SevereHalyard convenience kits containing Medline Namic manifolds recalled due to particulates
FDA (Devices) · 2026-08-12
- CriticalHalyard convenience kits recalled due to potential particulates in manifolds
FDA (Devices) · 2026-08-12
- HighBreast biopsy needles recalled over particulates that can enter tissue
FDA (Devices) · 2026-02-18
- HighAlcon Custom Paks Surgical Procedure Packs recalled for cannula defects
FDA (Devices) · 2024-05-01