LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a… — Class II medical device recall Z-2150-2013
Terminated recall by Genzyme Corporation, A Sanofi Company, reported 2013-09-11, distributed nationwide. Product contains particulates (fibers)
| Recall number | Z-2150-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genzyme Corporation, A Sanofi Company, Woburn, MA, United States |
| Recall initiated | 2013-06-21 |
| Classified | 2013-09-03 |
| Reported by FDA | 2013-09-11 |
| Terminated | 2014-08-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, DE, DK, EG, ES, FI, FR, GB, HK, IE, IT, NL, PL, SA, SE, TR |
| Quantity | 652 units |
| Reason classes | specification failure |
Product
LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 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 temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Reason for recall
Product contains particulates (fibers)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2150-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.