Medtronic MiniMed recalls 55,724 Paradigm REAL-Time Veo insulin pumps distributed worldwide. The pumps can deliver too much insulin when raised or too little when lowered relative to the infusion site due to gravity-driven pressure changes. Patients should stop using the device and contact Medtronic MiniMed or their healthcare provider for instructions and refunds.
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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Model numbers: MMT-554 and MMT-754. Product: Paradigm REAL-Time Veo Insulin Pump. Sold worldwide. Recall date: 2026-02-13. Quantity: 55,724. Manufacturer: Medtronic MiniMed, Inc. Price: Not disclosed. Country of origin: Unknown.
The pump may over-deliver insulin when elevated relative to the infusion site and under-deliver when lowered. This is caused by changes in gravitational force affecting hydrostatic and hydrodynamic pressures at the infusion site. Over-delivery can cause severe hypoglycemia and death. Under-delivery can cause severe hyperglycemia, dehydration, ketoacidosis, or death.
No injuries or incidents have been reported.
1. Stop using the product. 2. Do not attempt to modify or bypass the device. 3. Follow the recall instructions provided by Medtronic MiniMed or your healthcare provider. 4. Contact Medtronic MiniMed for instructions and refunds.
Phone: Unknown. Website: https://www.medtronic.com. Hours: Unknown.
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