Medtronic

  • Model / Serial
    Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide throughout the United States and worldwide.
  • Product Description
    Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • 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

829 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots: A46413, A6414, A48711, A49692, A53066, A53867, A55500, A55753, A57046, A58460, A60519, A61343, A67224.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.
  • Product Description
    Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F
  • Manufacturer
  • Model / Serial
    Lots: A55754, A59282, A62361, A64132
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.
  • Product Description
    Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
  • Manufacturer
  • Model / Serial
    All serial numbers and Lot codes are affected.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and OUS to includeCanada, Europe, Middle East, Africa, Japan, Asia-Pacific, Australia - New Zealand, Latan America
  • Product Description
    Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions. Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via Extension and Lead. These components comprise the implantable portion of the Activa System.
  • Manufacturer
  • Model / Serial
    NJH701951H thru NJH801963H, NJH701965H, NJH701967H thru NJH701969H, NJH701971H thru NJH701975H, NJH701978H thru NJH701986H, NJH702007H, NJH702008H, NJH702028H, NJH702029H, NJH702032H, NJH702033H, NJH702035H, NJH702036H, NJH702038H, NJH702039H, NJH702044H, NJH702045H, NJH702144H, NJH702145H, NJH702146H, NJH702150H, NJH702152H, NJH702153H, NJH702157H, NJH702158H, NJH702159H, NJH702160H, NJH702162H, NJH702163H, NJH702164H, NJH702166H, NJH702168H, NJH702169H, NJH702171H thru NJH702175H, NJH702183H, NJH702184H, NJH702213H, NJH702215H, NJH702216H, NJH702263H, NJH702324H, NJH702425H, NJH702427H, NJH702428H, NJH702429H, NJH702434H, NJH702436H, NJH702438H, NJH702439H, NJH702441H, NJH702443H, NJH702447H, NJH702451H, NJH702452H, NJH702455H, NJH702458H, NJH702487H, NJH702765H, NJH702772H, NJH702809H, NJH702834H, NJH702852, NJH702862H, NJH702863H, NJH702919H, NJH702980, NJH702982H, NJH702990H, NJH702993H, NJH702999H, NJH703001H
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide (AZ, CA, FL, ID, IL, IN, KS, KY, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, and WI).
  • Product Description
    Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.
  • Manufacturer
  • Model / Serial
    Lot numbers 571, 606, 695, 754, 952, 945, 1024, 1066
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal
  • Product Description
    Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA
  • Manufacturer
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