Recall Z-2144-2013— Genzyme Corporation, A Sanofi Company
Class II · Terminated
Class II FDA medical device recall by Genzyme Corporation, A Sanofi Company, initiated 2013-06-21, terminated 2014-08-07. FDA's recall record names no specific 510(k) clearance for this event. 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. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.. Reason: Product contains particulates (fibers).
- Recalling firm
- Genzyme Corporation, A Sanofi Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-21
- Terminated
- 2014-08-07
- Firm location
- Woburn, MA, United States
Product description
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. 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.