BEUDAMED
    FDA Recall Open, Classified

    Paradigm Insulin Pump (MMT-712, MMT-715)

    Recall: Z-1748-2026 · Initiated February 13, 2026

    Recall

    Recall Number
    Z-1748-2026
    Event Number
    98186
    Firm
    Medtronic MiniMed, Inc.
    FEI Number
    3003166194
    Product Code
    LZG
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 13, 2026
    Posted
    April 2, 2026
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Paradigm Insulin Pump (MMT-712, MMT-715)

    Reason

    All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

    Action

    On 2/13/2026, communications began via email, SMS, certified postal mail, and in-app push notifications. Correction notices were sent informing customers of the following: User Guides will be updated to include: "It is important to keep the location of your pump stable relative to your infusion site. Do not wear or place your pump more than 14 in (35.5 cm) above your infusion site. Doing so can cause an over-delivery of insulin, which may result in hypoglycemia." User guides that are updated will be available at: https://www.medtronicdiabetes.com/download-library visit https://info.medtronicdiabetes.com/pump-placement for affected user guide versions. Required Actions: Keep the location of your insulin pump close to your infusion site. - If you need to raise the pump above your infusion site, such as when a parent or caregiver is using the pump for a child, limit the time that the pump is held above the infusion site. - Pay attention to any alerts from your pump as well as symptoms of hypoglycemia and hyperglycemia; follow your healthcare professional's treatment instructions in these situations. - If you have any concerns about how this may impact insulin delivery and blood glucose, please contact your healthcare professional. You may also contact firm at 1-855-587-4950 with any questions about this notification. -Complete and return the acknowledgement form by visiting https://info.medtronicdiabetes.com/pump-placement Distributor Partner / Service Provider: Send existing patients the Patient Notification. To HCPs send the HCP Notification and Patient Notification

    Distribution

    Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan, New Zealand, Australia, Bangladesh, Brunei Darussalam, Cambodia, Indonesia, Malaysia, Maldives, Philippines, Thailand, Vietnam, Singapore, Pakistan, Hong Kong, China, Argentina, Aruba, Barbados, Bermuda, Bolivia, Plurinational State Of, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, Puerto Rico, Trinidad And Tobago, Uruguay, Venezuela, Canada, South Korea, India, Albania, Algeria, Andorra, Armenia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guyana, French Polynes., Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malawi, Malta, Martinique, Mauritius, Mayotte, Moldavia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Qatar, Reunion, Romania, Russia, San Marino, Saudi Arabia, Serbia, Sierra Leone, Slovakia, Slovenia, South Africa, Spain, St.Pier,Miquel., Sudan, Sweden, Switzerland, Syrian Arab Republic, Tanzania, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Yemen, Zambia, Zimbabwe.

    Quantity

    73,656