Resolute Integrity Zotarolimuseluting Coronary Stent

  • Modèle / numéro de série
    Model: RSINT30034UX;  Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Resolute Integrity Zotarolimus-eluting Coronary Stent: || Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. || Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. || Minneapolis, MN. || Indicated for improving coronary luminal diameters in patients.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source