Events

Recall of Device Recall LeGoo Endovascular Occlusion Gel1.0 mL LeGoo with 3 Cannula Pouch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genzyme Corporation, A Sanofi Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65485
  • Event Risk Class
    Class 2
  • Event Number
    Z-2141-2013
  • Event Initiated Date
    2013-06-21
  • Event Date Posted
    2013-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119108
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Occluder, internal vessel, temporary - Product Code OBC
  • Reason
    Product contains particulates (fibers).
  • Action
    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.

Device

Device Recall LeGoo Endovascular Occlusion Gel1.0 mL LeGoo with 3 Cannula Pouch
  • Model / Serial
    All lot codes
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch || Product Number: CS-100 || 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.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company

Manufacturer

Genzyme Corporation, A Sanofi Company
  • Manufacturer Address
    Genzyme Corporation, A Sanofi Company, 175F New Boston St, Woburn MA 01801-6203
  • Manufacturer Parent Company (2017)
    Sanofi
  • Source
    USFDA