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

FDA device recall Z-1748-2026 · posted 2026-04-02 · Open, Classified

Recall details

Recalling firm

Medtronic MiniMed, Inc.

Reason for recall

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 taken

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

Root cause

Device Design

Status

Open, Classified

Product code

LZG

Quantity affected

73,656

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

Date initiated

2026-02-13

Date posted

2026-04-02

Location

Northridge, CA

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