Events

Recall of Device Recall Medtronic MiniMed Paradigm Insulin Infusion Pumps

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
    64754
  • Event Risk Class
    Class 2
  • Event Number
    Z-1085-2013
  • Event Initiated Date
    2013-03-22
  • Event Date Posted
    2013-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116997
  • 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
    Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
  • Reason
    Medtronic is recalling the medtronic paradigm insulin pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. when the pump is expose to water it may result in damage to the pump's internal electronics. this moisture damage can prevent the pump's buttons from working properly or can cause the pump to alarm.
  • Action
    Medtronic sent an Urgent Medical Device Safety Notification letters to all affected customers. The recall letter informs the customers of the problem identified and the actions to be taken. The letter informs the healthcare professionals that Medtronic will inform their patients about the potential safety issues. Customers are instructed to find online information at www.medtronicdiabetes.com/support/product-updates. Customers are instructed to call Medtronic at 1.888.204.7616 (option 1 for loose drive support cap related questions and option 2 for water damage related questions). Distributors are instructed to provide Medtronic with an Excel spreadsheet list of all end users to whom they have shipped any of the listed serialized products.

Device

Device Recall Medtronic MiniMed Paradigm Insulin Infusion Pumps
  • Model / Serial
    Not available
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) the countries of: AE, AR, AT, AU, BA, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LC, LV, MK, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PR, PY, QA, RO, SA, SE, SG, SI, SK, SV, SY, TF, TH, TR, TT, TW, UA, UY, VE, ZA.
  • Product Description
    Medtronic MiniMed Paradigm Insulin Infusion Pumps || Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. || Product Usage: || Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
  • Manufacturer
    Medtronic MiniMed

Manufacturer

Medtronic MiniMed
  • Manufacturer Address
    Medtronic MiniMed, 18000 Devonshire St, Northridge CA 91325-1219
  • Source
    USFDA