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U.S. Department of Health and Human Services

Class 2 Device Recall LeGoo Endovascular Occlusion Gel2.5 mL LeGoo with 1 Cannula Pouch

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 Class 2 Device Recall LeGoo Endovascular Occlusion Gel2.5 mL LeGoo with 1 Cannula Pouchsee related information
Date Initiated by FirmJune 21, 2013
Date PostedSeptember 03, 2013
Recall Status1 Terminated 3 on August 07, 2014
Recall NumberZ-2147-2013
Recall Event ID 65485
PMA NumberP110003 
Product Classification Occluder, internal vessel, temporary - Product Code OBC
ProductLeGoo Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 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.
Code Information All lot codes
Recalling Firm/
Manufacturer		 Genzyme Corporation, A Sanofi Company
175F New Boston St
Woburn MA 01801-6203
Manufacturer Reason
for Recall		Product contains particulates (fibers)
FDA Determined
Cause 2		Material/Component Contamination
ActionGenzyme 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.
Quantity in Commerce181 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = OBC
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