Skip to content

LEGOO Temporary Endovascular Occluder

by Genzyme Corp.

PMA P110003

LEGOO Temporary Endovascular Occluder is a Class III device made by Genzyme Corp., approved under FDA PMA P110003 on 28 Sep 2011, withdrawn as of 6 Oct 2026. 18 FDA recalls are linked to it.

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 28 Sep 2011

PMA

FDA recalls

None ongoing

18 closed

Documents

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP110003 Date28 Sep 2011Approval withdrawnStatusWithdrawn

Official records

Recalls

18 recalls · FDA

  • 18 recalls, same reason

    • Terminated Z-2153-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2145-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2143-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2155-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2141-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2140-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2139-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2144-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2142-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2152-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2146-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2148-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2147-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2149-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2154-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2151-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2156-2013 FDA Class II initiated 21 Jun 2013
    • Terminated Z-2150-2013 FDA Class II initiated 21 Jun 2013

    Product contains particulates (fibers)

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-2142-2013
  2. Recall initiated FDA recalls Z-2152-2013
  3. Recall initiated FDA recalls Z-2146-2013
  4. Recall initiated FDA recalls Z-2148-2013
  5. Recall initiated FDA recalls Z-2147-2013
  6. Recall initiated FDA recalls Z-2149-2013
  7. Recall initiated FDA recalls Z-2154-2013
  8. Recall initiated FDA recalls Z-2151-2013
  9. Recall initiated FDA recalls Z-2156-2013
  10. Recall initiated FDA recalls Z-2150-2013

9 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Full name
Legoo
Generic name
Occluder, internal vessel, temporary
PMA number
FDA product code
OBC
Device class
Class III
Advisory committee
Cardiovascular
FDA decision
APWD Approval withdrawn

Other devices from Genzyme Corp.

See all devices from Genzyme Corp. →