Genzyme Corporation, A Sanofi Company: Medical Device Recall in 2013 - (Recall #: Z-2154-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT 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.

Product Classification:

Class II

Date Initiated: June 21, 2013

Date Posted: September 11, 2013

Recall Number: Z-2154-2013

Event ID: 65485

Reason for Recall:

Product contains particulates (fibers)

Status: Terminated

Product Quantity: 110 units

Code Information:

All lot codes

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated