Devices

6F Taiga Guiding Catheter

  • Modèle / numéro de série
    Lot/Serial Number's: 0008104881, 0008185945, 0008448845, 0008498609, 0008591678, 0008603130, 0008128237, 0008185937, 0008359341, 0008381347, 0008520748, 0008572204, 0008584614, 00 887489, 0008132544, 0008143685, 0008153935, 0008176874, 0008181991, 0008189749, 0008195422, 0008220305, 0008399842, 0008411526, 0008479077, 0008498645, 0008510155, 0008560305, 0008588040, 0008609897, 0008614083, 0008092512, 0008117850, 0008171020,  0008173080, 0008185946, 0008195426, 0008250618, 0008374572, 0008399835, 0008411525, 0008510141, 0008584625, 0008589932, 0008609899, 0008084699, 0008092511, 0008143683, 0008156792, 0008169119, 0008191347, 0008448842, 0008479041, 0008498608,  0008527623, 0008090683, 0008121917, 0008128241, 0008148608, 0008169116, 0008191339, 0008401589, 0008503947, 0008510133, 0008580930, 0008580935, 0008580939, 0008589915, 0008121924, 0008132534, 0008150901, 0008401588, 0008418561, 0008441398,  0008448854, 0008503956, 0008588042, 0008603140, 0008614065, 0008087481, 0008090682, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Japan
  • Description du dispositif
    6F Taiga Guiding Catheter
  • Manufacturer
    Medtronic Inc
  • 1 Event

Fabricant

Medtronic Inc
  • Adresse du fabricant
    Medtronic Inc, 710 Medtronic Pkwy, NE Mailstop LS245, Minneapolis MN 55432-5603
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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
    USFDA