CLASS II Device recall · Reported 11 Sep 2013 · FDA Enforcement Report

LeGoo Internal Vessel Occluder Product Number recalled

Genzyme Corporation A Sanofi is recalling LeGoo Internal Vessel Occluder Product Number: 10-0500 LeGoo is a water-soluble, distributed nationwide in the US. The recall was initiated on 21 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot codes

Quantity recalled308 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2152-2013
FDA event ID: 65485
Recalling firm: Genzyme Corporation A Sanofi, Woburn, MA
Classification: Class II
Status: Terminated
Recall initiated: 21 Jun 2013
FDA classified: 3 Sep 2013
Reported: 11 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Heart & Vascular Devices

Timeline

21 Jun 2013	Recall initiated by company
3 Sep 2013	Classified by FDA	+74 days
11 Sep 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product contains particulates (fibers)

Product as listed by the FDA

LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 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 occlusion of blood vessels up to 4 mm in diameter below the neck.

Where it was distributed

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

Nationwide

Questions about this recall

Why was it recalled?

Product contains particulates (fibers)

Which lots are affected?

All lot codes

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

17 other products · FDA event 65485

This product is part of a recall event; the main page for the event is LeGoo¿ Endovascular Occlusion Gel- LeGoo w/ no Cannula recalled.

Reported	Class	Recall	Company	Reason	Where
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo w/ no Cannula recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo Internal Vessel Occluder . Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo Internal Vessel Occluder Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo Internal Vessel Occluder Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo Endovascular Occlusion Gel Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo w/ no Cannula recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo Endovascular Occlusion Gel Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo Endovascular Occlusion Gel Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo Internal Vessel Occluder Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo Internal Vessel Occluder . Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo w/ no Cannula recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide

More recalls from Genzyme Corporation A Sanofi

All 18

Reported	Class	Recall	Company	Reason	Where
11 Sep 2013Device	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013Device	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo w/ no Cannula recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013Device	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013Device	CLASS II	LeGoo Internal Vessel Occluder . Product Number recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide
11 Sep 2013Device	CLASS II	LeGoo¿ Endovascular Occlusion Gel- LeGoo recalled	Genzyme Corporation A Sanofi	Particulate Matter	Nationwide

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