Z-2141-2013Class II

LeGoo Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a...

Name: Z-2141-2013 LeGoo Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a...
Creator: Genzyme Corporation, A Sanofi Company
Published: 2013-06-21
License: https://open.fda.gov/license/

Genzyme Corporation, A Sanofi Company / initiated 2013-06-21 / Terminated / root cause: manufacturing process

FDA source

Genzyme Corporation, A Sanofi Company began a recall of 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... on 2013-06-21. FDA classified it as Class II and gives the reason as "Product contains particulates (fibers)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2141-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-21
Posted: 2013-09-03
Terminated: 2014-08-07
Recalling firm: Genzyme Corporation, A Sanofi Company
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 vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
Product code: OBC Occluder, Internal Vessel, Temporary
Reason for recall: Product contains particulates (fibers)
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087. For questions regarding this recall call 508-270-2285.
Quantity in commerce: 100 units
Distribution: 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.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2141-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2139-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2140-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2141-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2142-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2143-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2144-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2145-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2146-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2147-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2148-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2149-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2150-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2151-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2152-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2153-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2154-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2155-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2156-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03

Product code OBC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)