FDA Device recall Z-2152-2013
LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive pr…
- FDA Device
- Class II
- terminated
- Published 2013-09-11
On 2013-09-11 the FDA classified a Class II recall of LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive pr… by Genzyme A Sanofi, citing product contains particulates (fibers).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2152-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-21 |
| Published | 2013-09-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Genzyme A Sanofi |
| Distribution | US |
Product
LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 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
Product contains particulates (fibers)
Identifiers
| code_info | All lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2152-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.