Agency classClass IIOur severity:High FDA (Devices)·Z-2155-2013·Announced 2013-09-11

Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 220 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The presence of particulates in an injectable medical device presents a risk of harm, but no specific injuries or illnesses are reported in the source text, placing it in the High severity category per the rubric.

Plain-English summary

Genzyme Corporation, a Sanofi company, is recalling 220 units of LeGoo Endovascular Occlusion Gel 1.0 mL (Product Number: LG100IT). 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 product was 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. All lot codes are included in this recall.

The U.S. Food and Drug Administration has classified this as a Class II recall. 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 Product Number: LG100IT 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…
Manufacturer: Genzyme Corporation, A Sanofi Company
Category: Medical Device — Endovascular Gel
Hazard: particulates
fibers
Affected units: 220

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 · particulates