Device recall
Z-2152-2013: LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a…
FDA device recall · Class II · Genzyme Corporation, A Sanofi Company
Key facts
| Recall number (Z-number) | Z-2152-2013 |
|---|---|
| Recall event | 65485 |
| 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… |
| Product code | OBC |
| Recalling firm | Genzyme Corporation, A Sanofi Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2014 |
| PMA numbers | P110003 |
| FEI number | 3008867907 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database