Device Recall Medtronic Custom Kits

  • Model / Serial
    Lot Numbers: 0000574290, 0000574314, 0000574316, 0000580205, 0000608559, 0000618615, 0000640122, 0000640634, 0000771456, 0000772227, 0000777567, 0000780964, 0000781651, 0000800394, 0000920163, 0000739503 and 0000950662.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • Product Description
    Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Cardiovascular Revascularization & Surgical Therap, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 0000567714, 0000569193, 0000569453, 0000571627, 0000574238, 0000579154, 0000579157 and 0000580322.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • Product Description
    Medtronic One Source Pack Magellan, Catalog Number: COS310. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories. || Medtronic Ideal MAXPAC Total System
  • Manufacturer
  • Model / Serial
    Lot Numbers: 0000570588, 0000574333, 0000597907, 0000597954, 0000603799, 0000603854, 0000604000, 0000604584, 0000604619, 0000607627, 0000611283, 0000617833, 0000624995, 0000628687, 0000641735, 0000644599, 0000645307, 0000648997, 0000653336, 0000654111, 000065606, 0000662898, 0000666630, 0000666650, 0000676750, 0000680771, 0000682337, 0000697089, 0000699592, 0000708267, 0000708363, 0000712299, 0000721526, 0000727448, 0000738389, 0000756494, 0000762708, 0000797022, 0000805167, 0000805376, 0000806225, 0000806808, 0000812913, 0000838110, 0000846202, 0000849687, 0000850497, 0000854152, 0000854999, 0000856172 and 0000969188.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • Product Description
    Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. || Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
  • Manufacturer