ATTAIN HYBRID Guide Wire

  • Model / Serial
    0006752371 0006752383 0006752385 0006759937 0006759939 0006759941 0006769772 0006781453 0006781454 0006781455 0006808160 0006808161 0006808164 0006808165 0006808166 0006808167 0006831243 0006840866 0006840878 0006840879 0006866694 0006866696 0006866697 0006873688 0006873692 0006873694
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.
  • Product Description
    ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 || The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • 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

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    See FSN | See FSN (device manufacturing April 2013-October 2013)
  • Product Description
    MD: Cardiac catheter guidewire, single-use
  • Manufacturer
  • Model / Serial
    ATTAIN HYBRID Guide Wires (used to aid the placement of Medtronic transvenous left ventricular leads in the coronary vasculature)Model GWR419688Batch Numbers: 0006840866, 0006840879, 0006873688ARTG Number: 153354
  • Product Classification
  • Manufacturer