LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 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.
Recall
- Recall Number
- Z-2149-2013
- Event Number
- 65485
- Firm
- Genzyme Corporation, A Sanofi Company 175F New Boston
- FEI Number
- 3008867907
- Product Code
- OBC
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- June 21, 2013
- Posted
- September 3, 2013
- Terminated
- August 7, 2014
- Address
- St Woburn, MA, 01801-6203
Description
LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 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 contains particulates (fibers)
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087. For questions regarding this recall call 508-270-2285.
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.
776 units