Device Recall TRUE Dilatation Balloon Valvuloplasty Catheter

  • Modèle / numéro de série
    All lot numbers lower than PLN00749 are subject to this recall.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.
  • Description du dispositif
    TRUE Dilatation Balloon Valvuloplasty Catheter, || REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: || 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; || Intended to be used for balloon aortic valvuloplasty.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Loma Vista Medical, 863 Mitten Rd Ste 100A, Burlingame CA 94010-1307
  • Société-mère du fabricant (2017)
  • Source