Agency classClass IIOur severity:High FDA (Devices)·Z-2141-2013·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 covers 100 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are categorized as High severity.

Plain-English summary

Genzyme Corporation, a Sanofi company, is recalling 100 units of LeGoo Endovascular Occlusion Gel-1.0 mL with 3 Cannula Pouch (Product Number: CS-100). 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 various countries including Austria, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK.

The FDA has classified this recall as Class II, which means the use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote. Users should contact the manufacturer for further instructions regarding the affected product.

The recalled product

Product: 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…
Manufacturer: Genzyme Corporation, A Sanofi Company
Category: Medical Device — Endovascular Occlusion Gel
Hazard: particulates
fibers
Affected units: 100

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