Events

Recall of Device Recall Medtronic MiniMed paradigm mio Infusion Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Minimed.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59960
  • Event Risk Class
    Class 2
  • Event Number
    Z-0202-2012
  • Event Initiated Date
    2011-05-16
  • Event Date Posted
    2011-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104110
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • Reason
    The consignee received four (4) boxes of mio infusion sets (mmt-921) that were shipped to them in error. these infusion sets were shipped in a package that included a minimed paradigm real-time insulin pump among other items. the mio infusion sets were not authorized to be shipped to the consignee based on medtronics internal product handling procedures and they may not function properly. t.
  • Action
    The firm, Medtronic, sent an "IMPORTANT RECALL INFORMATION" letter dated May 16, 2011 to consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue use right away; use the replacement mio infusion sets provided to them in this package; return all unused Lot 3700255 mio infusion sets using the emailed pre paid return label, and drop the package off at any UPS location or call UPS at 800.742.5877 to schedule a pick up. "Please note that only the Lot 3700255 mio infusion sets were shipped in error. The other products included in the package were not shipped in error and do not need to be returned." If you have any additional questions relating to this notification or any questions in general call 800.999.9859 ext.63704.

Device

Device Recall Medtronic MiniMed paradigm mio Infusion Sets
  • Model / Serial
    Lot Number 3700255
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AL only.
  • Product Description
    Medtronic MiniMed paradigm mio Infusion Sets MMT-921 || The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum.
  • Manufacturer
    Medtronic Minimed

Manufacturer

Medtronic Minimed
  • Manufacturer Address
    Medtronic Minimed, 1800 Devonshire Street, Northridge CA 91325
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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