Device Recall Maverick 2" Monorail PTCA Catheter

  • Modèle / numéro de série
    Lots: 6240888, Exp January 2007; 6240363, Exp January 2007.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.
  • Description du dispositif
    Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-1225 || Use before 2007-01 || UPN H7493892812250 || Sterilized with ethylene oxide gas || Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-2035 || Use before 2007-01 || UPN H7493892820350 || Sterilized with ethylene oxide gas || Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA