Device Recall Trevo Pro 4 Stent Retriever

  • Modèle / numéro de série
    Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: CA, IN, PA, AL, and NJ.
  • Description du dispositif
    Trevo Pro 4 Stent Retriever, || Model number 80021; || U.S. Indications for use: The Trevo Retriever is intended to restore blood || flow in the neurovasculature by removing thrombus in patients experiencing || ischemic stroke within 8 hours of symptom onset. Patients who are ineligible || for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA || therapy are candidates for treatment.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Société-mère du fabricant (2017)
  • Source
    USFDA