Agency classClass IIOur severity:High FDA (Devices)·Z-2149-2013·Announced 2013-09-11

Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates

Genzyme Corporation is recalling 776 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury is assigned a score of 3 (High), representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Genzyme Corporation, a Sanofi company, is recalling 776 units of the LeGoo Internal Vessel Occluder .5mL (Product Number: 10-0050). The recall was initiated because the product contains particulates, specifically fibers. LeGoo is a water-soluble, biocompatible polymer used for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

The affected units were distributed worldwide, including nationwide in the United States and internationally to countries such as Austria, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Hong Kong, Ireland, Italy, the Netherlands, Poland, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom. The recall includes all lot codes for this product.

Healthcare providers and patients should stop using the affected LeGoo Internal Vessel Occluder units and contact Genzyme Corporation for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 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…
Manufacturer: Genzyme Corporation, A Sanofi Company
Category: Medical Device — Endovascular Occlusion Device
Hazard: contamination
particulates
Affected units: 776

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lot codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by Genzyme Corporation, A Sanofi Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

Same manufacturer · Genzyme Corporation, A Sanofi Company

See all →

High
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
FDA (Devices) · 2013-09-11
High
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
FDA (Devices) · 2013-09-11
High
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates
FDA (Devices) · 2013-09-11
High
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
FDA (Devices) · 2013-09-11
High
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
FDA (Devices) · 2013-09-11

Same hazard · contamination