Device recall: LeGoo Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble…
Class II FDA enforcement event 65485. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product contains particulates (fibers)
Class II, in the words of FDA
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
Genzyme Corporation, A Sanofi Company started this device recall on 21 Jun 2013. The firm address in the FDA record is in Woburn, MA. FDA put the recall in Class II. FDA event 65485 has 18 product records. The first FDA enforcement report date is 11 Sep 2013. The record gives the status Terminated, with the termination date 7 Aug 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi…
Recalling firm
Genzyme Corporation, A Sanofi Company, Woburn, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
18 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2139-2013 | LeGoo Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 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… | 30 units | Class II | Terminated | 11 Sep 2013 |
| Z-2140-2013 | LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 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… | 65 units | Class II | Terminated | 11 Sep 2013 |
| Z-2141-2013 | 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… | 100 units | Class II | Terminated | 11 Sep 2013 |
| Z-2142-2013 | LeGoo Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 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… | 5 units | Class II | Terminated | 11 Sep 2013 |
| Z-2143-2013 | LeGoo Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-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… | 45 units | Class II | Terminated | 11 Sep 2013 |
| Z-2144-2013 | LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 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… | 250 units | Class II | Terminated | 11 Sep 2013 |
| Z-2145-2013 | LeGoo Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 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… | 660 units | Class II | Terminated | 11 Sep 2013 |
| Z-2146-2013 | 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 vessel. LeGoo is indicated for temporary… | 994 units | Class II | Terminated | 11 Sep 2013 |
| Z-2147-2013 | LeGoo Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 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… | 181 units | Class II | Terminated | 11 Sep 2013 |
| Z-2148-2013 | LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 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… | 448 units | Class II | Terminated | 11 Sep 2013 |
| Z-2149-2013 | LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 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… | 776 units | Class II | Terminated | 11 Sep 2013 |
| Z-2150-2013 | LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 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… | 652 units | Class II | Terminated | 11 Sep 2013 |
| Z-2151-2013 | LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 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… | 331 units | Class II | Terminated | 11 Sep 2013 |
| Z-2152-2013 | 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… | 308 units | Class II | Terminated | 11 Sep 2013 |
| Z-2153-2013 | LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 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… | 37 units | Class II | Terminated | 11 Sep 2013 |
| Z-2154-2013 | LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT 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… | 110 units | Class II | Terminated | 11 Sep 2013 |
| Z-2155-2013 | 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 for temporary endovascular occlusion of blood… | 220 units | Class II | Terminated | 11 Sep 2013 |
| Z-2156-2013 | LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT 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… | 100 units | Class II | Terminated | 11 Sep 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 18
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-2139-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 65485. https://recallregister.com/fda/ii/65485/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi…
- What quantity of product is in FDA event 65485?
- The event has 18 product records. The first record gives this quantity:
30 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.