Medtronic MiniMed recalled 29,074 Paradigm Real-Time insulin pumps worldwide. The devices may deliver insulin improperly when the pump is elevated or lowered relative to the infusion site due to gravitational effects. Patients should stop using the pumps immediately and follow recall instructions from the manufacturer and their healthcare provider.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic MiniMed, Inc. or your healthcare provider for instructions. Notification method: Letter
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Medtronic MiniMed Paradigm Real-Time insulin pumps are wearable devices used for continuous insulin delivery in diabetes management. They are part of a family of infusion pumps designed to automate insulin dosing.
The device can over-deliver insulin when elevated and under-deliver when lowered, due to changes in hydrostatic and hydrodynamic pressures. This can lead to severe hypoglycemia or diabetic ketoacidosis and potentially death.
This recall is not described as part of a broader industry pattern in the provided data.
The risk is life-threatening for some users. The recall affects patients who rely on these pumps for daily management and may require urgent medical oversight during replacement.
Recall notices are available from Medtronic and FDA enforcement reports. Useful identifiers include model number and device documentation.
4-8 weeks for refunds or replacements after initiating the recall process.
Keep recall letter, model numbers, serials, photos of device, and all correspondence with manufacturer and clinicians.
Models: MMT-522, MMT-722. Affected series: Paradigm Real-Time, MiniMed 600 series, BLE 700 series. Sold worldwide with US nationwide distribution in multiple states. Recall quantity: 29,074 units. Recall date: 2026-02-13. Manufacturer: Medtronic MiniMed, Inc. Price information: Unknown. Sold since: Unknown. Country of origin: Unknown.
No injuries or incidents have been reported.
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