Medtronic Inc

8 devices in the database

  • Model / Serial
    Lot Numbers: 10058759, 9984675, 9956368, 9916066, 989741, 9875810, 9866275, 9854094, 9828585, 9812351, 9421573, 9169873, 9044915, 8956269, 8938159, 8885755 and 8765243.   Serial Numbers: IH31608 - IH32031.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution USA including states of CA, CO, FL, IL, IN, KY, LA, MD, MI, MN, MO, NV, NJ, NY, OH, OK PA, TN, TX, UT, VA, and WI, and countries of LATVIA, ITALY, ARMENIA, RUSSIAN FEDERATION, POLAND, CHILE and CHINA.
  • Product Description
    Medtronic Surgical Membrane Oxygenator. || Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene Oxide, REF 61399402655, Manufacturer: Medtronic Inc., Minneapolis, MN 55432-5604. || Surgical Membrane Oxygenators are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures. Additionally, the Integral Membrane Oxygenators are intended to cool and warm the blood by means of the integral heat exchange.
  • 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.
  • Model / Serial
    Lot #: 1093645, 1102929, 1139554
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CO, JAPAN, CHINA.
  • Product Description
    ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604.
  • Model / Serial
    Catalogue Number 30514
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    All states in USA (Including DC) except RI and VT.
  • Product Description
    Medtronic HMS PLUS, Hemostasis Management System, Model 30514. || It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. || It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
  • Model / Serial
    Lot #: 1058285, 10059556, 1099512, 1106926, 1106983, 1001369.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CO, JAPAN, CHINA.
  • Product Description
    IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.
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91 manufacturers with a similar name

Learn more about the data here

  • 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
    TDMDAT
  • 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
    TDMDAT
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
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