Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2153-2013 — LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 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 o

U.S. FDA — Device Enforcement · United States · 2013-06-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2153-2013
Date of alert: 2013-06-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Genzyme Corporation, A Sanofi Company
Product category: device
Product type: Devices

Reported risk: Product contains particulates (fibers)

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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