Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2146-2013·Announced 2013-09-11

Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

Genzyme Corporation is recalling 994 units of LeGoo Endovascular Occlusion Gel 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves particulates (fibers) in a medical device, which is a quality defect without reported injuries or deaths in the source text, fitting the criteria for a moderate severity recall.

Plain-English summary

Genzyme Corporation, A Sanofi Company, is recalling 994 units of LeGoo Endovascular Occlusion Gel, Product Number LG100. The recall was initiated because the product contains particulates, specifically fibers.

LeGoo is a water-soluble, biocompatible polymer indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. The affected units were distributed nationwide in the United States and internationally to Austria, Belgium, Canada, Denmark, Egypt, Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK.

The recall includes all lot codes. Consumers and healthcare providers should stop using the affected product and contact Genzyme Corporation for further instructions.

The recalled product

Product: LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 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…
Manufacturer: Genzyme Corporation, A Sanofi Company
Category: Medical Device — Endovascular Gel
Hazard: contamination
particulates
Affected units: 994

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 →

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