Resolute Integrity Zotarolimuseluting Coronary Stent

  • Model / Serial
    Model: RSINT30034UX;  Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    USFDA